Trial Outcomes & Findings for A First Study in Healthy Volunteers of a New Mobile Phone Application Measuring the Eyes Before and After Medication (NCT NCT05731999)
NCT ID: NCT05731999
Last Updated: 2025-04-02
Results Overview
For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt".
COMPLETED
NA
48 participants
Day 7 +/- 2 days (Visit 2)
2025-04-02
Participant Flow
48 subjects were included in the Full Analysis Set (FAS), 12 subjects per medicinal product type.
Participant milestones
| Measure |
Healthy Volunteers With Single Application of Phenethylamines (D1)
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group.
|
Healthy Volunteers With Single Application of Benzodiazepines (D2)
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiazepines (D2) allocated to this specific group.
|
Healthy Volunteers With Single Application of Cannabinoids (D3)
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group.
|
Healthy Volunteers With Single Application of Opioids (D4)
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Healthy Volunteers With Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group.
|
Healthy Volunteers With Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiazepines (D2) allocated to this specific group.
|
Healthy Volunteers With Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group.
|
Healthy Volunteers With Single Application of Opioids (D4)
n=12 Participants
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group.
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
26.25 Years
STANDARD_DEVIATION 12.90 • n=12 Participants
|
27.92 Years
STANDARD_DEVIATION 14.68 • n=12 Participants
|
27.75 Years
STANDARD_DEVIATION 17.35 • n=12 Participants
|
28.00 Years
STANDARD_DEVIATION 16.60 • n=12 Participants
|
27.48 Years
STANDARD_DEVIATION 15.00 • n=48 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=12 Participants
|
9 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
34 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
14 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Eye color
Eye color - blue
|
7 Participants
n=12 Participants
|
2 Participants
n=12 Participants
|
7 Participants
n=12 Participants
|
8 Participants
n=12 Participants
|
24 Participants
n=48 Participants
|
|
Eye color
Eye color - grey
|
2 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
3 Participants
n=48 Participants
|
|
Eye color
Eye color - green
|
0 Participants
n=12 Participants
|
5 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
6 Participants
n=48 Participants
|
|
Eye color
Eye color - amber
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=48 Participants
|
|
Eye color
Eye color - brown
|
3 Participants
n=12 Participants
|
4 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
3 Participants
n=12 Participants
|
13 Participants
n=48 Participants
|
|
Eye color
Eye color - black
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=48 Participants
|
|
Eye color
Eye color - other
|
0 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=12 Participants
|
2 Participants
n=48 Participants
|
|
Audit questionnaire
|
4.42 Score on a scale
STANDARD_DEVIATION 1.08 • n=12 Participants
|
3.83 Score on a scale
STANDARD_DEVIATION 2.12 • n=12 Participants
|
4.5 Score on a scale
STANDARD_DEVIATION 2.11 • n=12 Participants
|
5.08 Score on a scale
STANDARD_DEVIATION 1.62 • n=12 Participants
|
4.46 Score on a scale
STANDARD_DEVIATION 1.79 • n=48 Participants
|
PRIMARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS population. Participating subjects were allowed to have several attempts per test if needed. Consequently the number of analyzed attempts differ between groups and also between the different test types (NC, NY, TR, PLR, RED).
For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using native pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt".
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=320 Number of attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=329 Number of attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=339 Number of attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=336 Number of attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
Successful attempts - Non-convergence (NC)
|
295 Number of attempts
|
286 Number of attempts
|
317 Number of attempts
|
300 Number of attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
Successful attempts - Horizontal nystagmus (NY)
|
279 Number of attempts
|
242 Number of attempts
|
300 Number of attempts
|
282 Number of attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
Successful attempts - Tremor (TR)
|
295 Number of attempts
|
282 Number of attempts
|
319 Number of attempts
|
295 Number of attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
Successful attempts - Pupillary light reflex (PLR)
|
290 Number of attempts
|
297 Number of attempts
|
302 Number of attempts
|
307 Number of attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application Can be Used to Collect Pupillograms Before and Under the Influence of Phenethylamines, Benzodiazepines, Cannabinoids, and Opioids (D1-D4).
Successful attempts - Redness (RED)
|
314 Number of attempts
|
317 Number of attempts
|
312 Number of attempts
|
325 Number of attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS population. Participating subjects were allowed to have several attempts per test if needed. Consequently the number of analyzed attempts differ between groups and also between the different test types (NC, NY, TR, PLR, RED).
For each medicinal product (D1-D4), the fraction of collected pupillometry data from the mobile phone application at baseline and under the influence of D1-D4, which can be transformed into pre-defined key features using refined pupillogram. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A successful transformation is characterised by underlying quality control algorithms approving the extracted magnitude, where poor quality pupillograms are rejected from analysis. Each attempt to transform a pupillogram into key features is denoted an "Attempt", and the successful transformation is denoted a "Successful attempt.
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=320 Successful attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=329 Successful attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=339 Successful attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=336 Successful attempts
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).
Successful attempts - Pupillary light reflex (PLR)
|
294 Successful attempts
|
303 Successful attempts
|
309 Successful attempts
|
317 Successful attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).
Successful attempts - Redness (RED)
|
314 Successful attempts
|
317 Successful attempts
|
312 Successful attempts
|
325 Successful attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).
Successful attempts - Horizontal nystagmus (NY)
|
281 Successful attempts
|
241 Successful attempts
|
305 Successful attempts
|
281 Successful attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).
Successful attempts - Tremor (TR)
|
295 Successful attempts
|
282 Successful attempts
|
319 Successful attempts
|
295 Successful attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Use of Self-administered Pupillometry Using a Mobile Phone Application, After Refining the Method for Establishing Pupillograms, Can be Used to Collect Pupillograms Before and Under the Influence of Each Medicinal Product (D1-D4).
Successful attempts - Non-convergence (NC)
|
296 Successful attempts
|
282 Successful attempts
|
318 Successful attempts
|
297 Successful attempts
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS population.
For each medicinal product (D1-D4), number of changed key features from baseline to the LC-MS/MS (Liquid Chromatography Tandem Mass-Spectroscopy) verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. Each of the 24 key features represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and peak concentration is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.
50 Lux
|
5 Number of key features
|
1 Number of key features
|
4 Number of key features
|
7 Number of key features
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Key Features With Change From Baseline to Peak Concentration in Plasma, Using Refined Pupillograms.
500 Lux
|
5 Number of key features
|
3 Number of key features
|
2 Number of key features
|
7 Number of key features
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS population.
For each medicinal product (D1-D4), number of significant correlations between key features and plasma concentration over time using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "correlated" if the slope in a linear regression is significantly different from zero (p\<0.05). The term correlated over time refers to data collected during 5 hours at Visit 2 after administration of D1-D4. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=24 Number of key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition.
50 LUX
|
5 Number of key features
|
6 Number of key features
|
7 Number of key features
|
10 Number of key features
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Key Features for Which Correlation Between Pupillometric Variables and Concentration in Plasma Over Time is Significant for Each Medicinal Product D1-D4 and Ambient Light Condition.
500 LUX
|
7 Number of key features
|
4 Number of key features
|
2 Number of key features
|
9 Number of key features
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS population.
For each medicinal product (D1-D4), number of changed key features from baseline to 5 hours after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A key feature is considered "changed" if the difference between averages at baseline and at 5 hours is significant (p\<0.05). Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions.
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=24 Number of Key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=24 Number of Key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=24 Number of Key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=24 Number of Key features
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.
500 LUX
|
5 Number of Key features
|
5 Number of Key features
|
0 Number of Key features
|
6 Number of Key features
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Key Features With Change From Baseline to 5 Hours After Administration of Medicinal Product, Using Refined Pupillograms.
50 LUX
|
6 Number of Key features
|
1 Number of Key features
|
2 Number of Key features
|
8 Number of Key features
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS population. Obtained measurement data included for all subjects where available. Data for 500 Lux Kay feature Dbase missing for one subject in group D4 (opioid group). Consequently, data from 11 subjects presented for this variable.
For each medicinal product (D1-D4), evaluate known combinations of key features that changes from baseline to the LC-MS/MS verified peak concentration in plasma after administration of medicinal product at visit 2 using refined pupillograms. A key feature represents an eye characteristic (such as pupil size, iris position, and the similar). A combination of key features collected at peak plasma concentration was used to build a logistic regression classifier, and the resulting counts of true positives, true negatives, false positives, and false negatives are presented. Key features were available from two conditions, one condition where pupillograms and corresponding key features were collected in dim ambient light (50 Lux) and one condition where pupillograms and corresponding key features were collected in bright ambient light (500 Lux). The Outcome Measure is reported for both ambient light conditions. Key feature values were missing in a few instances, as shown in the table.
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
At baseline number of true negative
|
12 Number of participants
|
12 Number of participants
|
12 Number of participants
|
10 Number of participants
|
11 Number of participants
|
12 Number of participants
|
12 Number of participants
|
12 Number of participants
|
11 Number of participants
|
12 Number of participants
|
11 Number of participants
|
|
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
At baseline number of false positive
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
2 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
At baseline, missing key feature data
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
|
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
At peak concentration number of true positive
|
12 Number of participants
|
12 Number of participants
|
12 Number of participants
|
11 Number of participants
|
10 Number of participants
|
10 Number of participants
|
11 Number of participants
|
8 Number of participants
|
9 Number of participants
|
12 Number of participants
|
11 Number of participants
|
|
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
At peak concentration number of false negative
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
3 Number of participants
|
1 Number of participants
|
0 Number of participants
|
0 Number of participants
|
|
Number of Correct Classifications of Subjects, Evaluated Using a Combination of Different Pupillometric Variables for Indicating Use of Each Medicinal Product D1-D4 and Ambient Light Condition.
At peak concentration, missing key feature data
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
0 Number of participants
|
1 Number of participants
|
1 Number of participants
|
1 Number of participants
|
0 Number of participants
|
2 Number of participants
|
0 Number of participants
|
1 Number of participants
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 1. How would you grade the instructions for use? Response options: * Not understandable * Could only understand some parts * Could understand most parts * Could understand almost every part * Fully understandable
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 1
Could understand almost every part
|
1 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 1
Fully understandable
|
11 Participants
|
6 Participants
|
7 Participants
|
9 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 1
Could understand most parts
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 1
Could only understand some parts
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 1
Not understandable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 2. Was Previct Drugs easy to use correctly based on the information in the Instructions For Use (IFU)? Response options: * Yes * No
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 2
Yes
|
11 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 2
No
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 4. How did you experience the verbal instructions during a test with Previct Drugs? Response options: * Very easy to understand * Easy to understand * Nor easy or difficult to understand * Difficult to understand * Very difficult to understand
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 4
Very easy to understand
|
11 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 4
Easy to understand
|
1 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 4
Nor easy or difficult to understand
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 4
Difficult to understand
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 4
Very difficult to understand
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 5. Before starting a test, the App prompted you with a few written instructions. Did you read the instructions? Response options: * Yes * No
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 5
Yes
|
12 Participants
|
10 Participants
|
9 Participants
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 5
No
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 7. How did you experience performing a test with Previct Drugs (from opening of the App until the test was completed)? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 7
Easy to perform
|
7 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 7
Very easy to perform
|
5 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 7
Nor easy or difficult to perform
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 7
Difficult to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 7
Very difficult to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 8. During a test with Previct Drugs, did you at any time have to tilt the mobile against something to be able to perform a measurement? Response options: * Yes * No
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 8
Yes
|
4 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 8
No
|
8 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 9. If Yes (to question 8), how often did you have to tilt the mobile against something: Response options: * One occasion * Several occasions * Most occasions * All occasions
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 9
One occasion
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 9
Several occasions
|
3 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 9
Most occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 9
All occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 9
Missing
|
8 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 10. According to you, how many minutes did a test with Previct Drugs take in general? From start to end. Response options: * \< 5 minutes * 5-7 minutes * \> 7 minutes
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 10
< 5 minutes
|
5 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 10
5-7 minutes
|
5 Participants
|
6 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 10
> 7 minutes
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 11. Did you receive a notification when it was time for a test with Previct Drugs? Response options: * Yes * Most of the times * I did not receive any notifications
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 11
Yes
|
2 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 11
Most of the times
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 11
I did not receive any notifications
|
8 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 12. Did you notice any issues during usage of Previct Drugs? Response options: * No * Yes
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 12
No
|
5 Participants
|
9 Participants
|
3 Participants
|
8 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 12
Yes
|
7 Participants
|
3 Participants
|
9 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 13. Did you require any assistance from the study personnel (e.g., through phone) during the usage of Previct Drugs? Response options: * Yes * No
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 13
Yes
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 13
No
|
12 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 15. If Yes (to question 13), how often did you require assistance? Response options: * One occasion * Several occasions * Most occasions * All occasions
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 15
One occasion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 15
Several occasions
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 15
Most occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 15
All occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 15
Missing
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 15
Not applicable
|
11 Participants
|
11 Participants
|
10 Participants
|
10 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 16. When starting a measurement, how was your experience finding the right conditions to start the measurement? Response options: * Very easy * Easy * Nor easy or difficult * Difficult * Very difficult
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 16
Very easy
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 16
Easy
|
7 Participants
|
10 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 16
Nor easy or difficult
|
4 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 16
Difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 16
Very difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 18. How did you experience performing a Nystagmus (look to your extreme right and left) test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 18
Very easy to perform
|
5 Participants
|
6 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 18
Easy to perform
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 18
Nor easy or difficult to perform
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 18
Difficult to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 18
Very difficult to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 20. According to you, how many minutes did a Nystagmus test take (from starting test until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 20
< 1 minute
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 20
1-2 minutes
|
7 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 20
> 3 minutes
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 21. How often did you have to redo a Nystagmus test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 21
No occasion
|
7 Participants
|
8 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 21
One occasion
|
5 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 21
Several occasions
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 21
Most occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 21
All occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 23. In general, how easy is it for you to cross your eyes? Response options: * Very easy * Easy * Nor easy or difficult * Difficult * Very difficult
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 23
Very easy
|
5 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 23
Easy
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 23
Nor easy or difficult
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 23
Difficult
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 23
Very difficult
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 24. How did you experience performing a Cross Eyes test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 24
Very easy to perform
|
5 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 24
Easy to perform
|
5 Participants
|
6 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 24
Nor easy or difficult to perform
|
2 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 24
Difficult to perform
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 24
Very difficult to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 26. According to you, how many minutes did a Cross Eyes test take (from starting until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 26
< 1 minute
|
4 Participants
|
6 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 26
1-2 minutes
|
7 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 26
> 3 minutes
|
1 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 27. How often did you have to redo a Cross Eyes test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 27
No occasion
|
10 Participants
|
9 Participants
|
7 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 27
One occasion
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 27
Several occasions
|
0 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 27
Most occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 27
All occasions
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 29. How did you experience performing a Contraction test? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 29
Very easy to perform
|
2 Participants
|
2 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 29
Easy to perform
|
6 Participants
|
5 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 29
Nor easy or difficult to perform
|
4 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 29
Difficult to perform
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 29
Very difficult to perform
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 31. How was your experience turning your mobile when asked to? Response options: * Very easy to perform * Easy to perform * Nor easy or difficult to perform * Difficult to perform * Very difficult to perform
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 31
Very easy to perform
|
5 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 31
Easy to perform
|
5 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 31
Nor easy or difficult to perform
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 31
Difficult to perform
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 31
Very difficult to perform
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 33. According to you, how many minutes did a Contraction test take (from starting test until analyzed)? Response options: * \< 1 minute * 1-2 minutes * \> 3 minutes
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 33
< 1 minute
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 33
1-2 minutes
|
5 Participants
|
9 Participants
|
8 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 33
> 3 minutes
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7 +/- 2 days (Visit 2)Population: FAS
User-friendliness of Previct Drugs evaluated by the subject at visit 2. Question 34. How often did you have to redo a Contraction test? Response options: * No occasion * One occasion * Several occasions * Most occasions * All occasions
Outcome measures
| Measure |
Single Application of Phenethylamines (D1)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of phenethylamines.
|
Single Application of Benzodiazepines (D2)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids (D3)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids (D4)
n=12 Participants
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Benzodiazepines - 500 Lux Key Feature NCdiff-NYave
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of benzodiazepines.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 50 Lux Key Feature MCA + Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Cannabinoids - 500 Lux Key Feature Redness+NYNumber
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of cannabinoids.
|
Single Application of Opioids - 50 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
Single Application of Opioids - 500 Lux Key Feature Dbase
Evaluation of Previct Drugs' function to measure pupils and eye movements and to evaluate if there are any changes in the pupillometric parameters before and after intake of opioids.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Usability Questionnaire - Question 34
Most occasions
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 34
No occasion
|
5 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 34
One occasion
|
3 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 34
Several occasions
|
4 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Usability Questionnaire - Question 34
All occasions
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Healthy Volunteers With Single Application of Phenethylamines (D1)
Healthy Volunteers With Single Application of Benzodiasepines (D2)
Healthy Volunteers With Single Application of Cannabinoids (D3)
Healthy Volunteers With Single Application of Opioids (D4)
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy Volunteers With Single Application of Phenethylamines (D1)
n=12 participants at risk
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Phenethylamines (D1) allocated to this specific group.
|
Healthy Volunteers With Single Application of Benzodiasepines (D2)
n=12 participants at risk
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Benzodiasepines (D2) allocated to this specific group.
|
Healthy Volunteers With Single Application of Cannabinoids (D3)
n=12 participants at risk
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Cannabinoids (D3) allocated to this specific group.
|
Healthy Volunteers With Single Application of Opioids (D4)
n=12 participants at risk
Evaluation of performance, safety, and usability of Previct Drugs when used in healthy volunteers allocated to one out of four medicinal products at Visit 2 to simulate drug use. Opioids (D4) allocated to this specific group.
|
|---|---|---|---|---|
|
Investigations
Sleepiness
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
16.7%
2/12 • Number of events 2 • From signed informed consent to study completion, an average of 10 days.
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
41.7%
5/12 • Number of events 5 • From signed informed consent to study completion, an average of 10 days.
|
|
Eye disorders
Double vision
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
41.7%
5/12 • Number of events 5 • From signed informed consent to study completion, an average of 10 days.
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
|
Nervous system disorders
Light headed, dizzy
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
33.3%
4/12 • Number of events 5 • From signed informed consent to study completion, an average of 10 days.
|
|
Nervous system disorders
Vasovagal reaction
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
16.7%
2/12 • Number of events 2 • From signed informed consent to study completion, an average of 10 days.
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
16.7%
2/12 • Number of events 2 • From signed informed consent to study completion, an average of 10 days.
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
|
Nervous system disorders
Nausea
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
8.3%
1/12 • Number of events 1 • From signed informed consent to study completion, an average of 10 days.
|
16.7%
2/12 • Number of events 2 • From signed informed consent to study completion, an average of 10 days.
|
50.0%
6/12 • Number of events 6 • From signed informed consent to study completion, an average of 10 days.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
0.00%
0/12 • From signed informed consent to study completion, an average of 10 days.
|
16.7%
2/12 • Number of events 2 • From signed informed consent to study completion, an average of 10 days.
|
25.0%
3/12 • Number of events 3 • From signed informed consent to study completion, an average of 10 days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60