Trial Outcomes & Findings for Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia (NCT NCT03838484)
NCT ID: NCT03838484
Last Updated: 2022-04-29
Results Overview
Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The False Alarm Error Rate will be measured by the proportion of incorrect responses.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Week 1
Results posted on
2022-04-29
Participant Flow
1 participant lost to follow-up
Participant milestones
| Measure |
Healthy: Placebo First, Nicotine Last
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
Healthy: Nicotine First, Placebo Last
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
SCZ: Placebo First, Nicotine Last
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
SCZ: Nicotine First, Placebo Last
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
4
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Healthy: Placebo First, Nicotine Last
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
Healthy: Nicotine First, Placebo Last
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
SCZ: Placebo First, Nicotine Last
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
SCZ: Nicotine First, Placebo Last
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effects of Transdermal Nicotine on Response Inhibition to Emotional Cues in Schizophrenia
Baseline characteristics by cohort
| Measure |
Healthy: Placebo First, Nicotine Last
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
Healthy: Nicotine First, Placebo Last
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
SCZ: Placebo First, Nicotine Last
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a nicotine patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
SCZ: Nicotine First, Placebo Last
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1. After a washout period, they will return and apply a placebo patch for up to two hours prior to behavioral and EEG task during the second visit in week 2.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 4 • n=93 Participants
|
38 years
STANDARD_DEVIATION 11 • n=4 Participants
|
33 years
STANDARD_DEVIATION 15 • n=27 Participants
|
26 years
STANDARD_DEVIATION 5 • n=483 Participants
|
33 years
STANDARD_DEVIATION 9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
4 participants
n=4 Participants
|
4 participants
n=27 Participants
|
4 participants
n=483 Participants
|
17 participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Week 1Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 1. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 1.
Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The False Alarm Error Rate will be measured by the proportion of incorrect responses.
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
False Alarm Error Rate
|
0.20 Proportion of incorrect responses
Standard Error 0.05
|
0.15 Proportion of incorrect responses
Standard Error 0.07
|
0.11 Proportion of incorrect responses
Standard Error 0.04
|
0.19 Proportion of incorrect responses
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Week 2Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 2. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 2.
Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The False Alarm Error Rate will be measured by the proportion of incorrect responses.
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
False Alarm Error Rate
|
0.18 Proportion of incorrect responses
Standard Error 0.03
|
0.13 Proportion of incorrect responses
Standard Error 0.06
|
0.15 Proportion of incorrect responses
Standard Error 0.02
|
0.23 Proportion of incorrect responses
Standard Error 0.04
|
PRIMARY outcome
Timeframe: Week 1Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 1. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 1.
Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The Omission Error Rate will be measured by the proportion of questions asked with a failure to respond.
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
Omission Error Rate
|
0.24 Proportion of omitted responses
Standard Error 0.04
|
0.29 Proportion of omitted responses
Standard Error 0.06
|
0.44 Proportion of omitted responses
Standard Error 0.06
|
0.27 Proportion of omitted responses
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Week 2Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 2. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 2.
Participants will be shown fearful, sad, angry, and disgust faces (negative valence) and neutral faces performed in 5 blocks (3 emotional blocks with angry/fearful/sad/disgust faces and 2 non-emotional blocks). In each block the subject is instructed on the go/no-go targets and will press a key ("Go") or withhold pressing a key ("NoGo"). The Omission Error Rate will be measured by the proportion of questions asked with a failure to respond.
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
Omission Error Rate
|
0.29 Proportion of omitted responses
Standard Error 0.07
|
0.23 Proportion of omitted responses
Standard Error 0.06
|
0.38 Proportion of omitted responses
Standard Error 0.10
|
0.30 Proportion of omitted responses
Standard Error 0.03
|
PRIMARY outcome
Timeframe: Week 1Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 1. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 1.
Time taken from stimulus presentation to button push during Go trials
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
Reaction Time for Correct Hits
|
485.09 Milliseconds
Standard Error 16.56
|
491.05 Milliseconds
Standard Error 16.50
|
468.96 Milliseconds
Standard Error 13.49
|
517.05 Milliseconds
Standard Error 4.66
|
PRIMARY outcome
Timeframe: Week 2Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 2. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 2.
Time taken from stimulus presentation to button push during Go trials
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
Reaction Time for Correct Hits
|
477.54 Milliseconds
Standard Error 15.06
|
511.10 Milliseconds
Standard Error 10.88
|
478.99 Milliseconds
Standard Error 18.36
|
490.67 Milliseconds
Standard Error 24.40
|
PRIMARY outcome
Timeframe: Week 1Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 1. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 1.
Time taken from stimulus presentation to button push during NoGo trials
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
Reaction Time for False Alarms
|
718.89 Milliseconds
Standard Error 36.52
|
658.20 Milliseconds
Standard Error 40.50
|
813.00 Milliseconds
Standard Error 48.83
|
692.95 Milliseconds
Standard Error 31.27
|
PRIMARY outcome
Timeframe: Week 2Population: Please note that this outcome measure specifically refers to the specified outcome measure time frame: week 2. Because this is a crossover trial, only a subset of the subjects completed each treatment (placebo or nicotine) during week 2.
Time taken from stimulus presentation to button push during NoGo trials
Outcome measures
| Measure |
Healthy: Placebo
n=5 Participants
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
Healthy: Nicotine
n=4 Participants
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Placebo
n=4 Participants
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
SCZ: Nicotine
n=4 Participants
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task during the first visit in week 1.
|
|---|---|---|---|---|
|
Reaction Time for False Alarms
|
727.30 Milliseconds
Standard Error 60.81
|
758.12 Milliseconds
Standard Error 69.68
|
769.95 Milliseconds
Standard Error 42.67
|
703.99 Milliseconds
Standard Error 23.82
|
Adverse Events
Healthy: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Healthy: Nicotine
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
SCZ: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SCZ: Nicotine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Healthy: Placebo
n=10 participants at risk
Healthy controls will apply placebo skin patch for up to two hours prior to behavioral and EEG task.
|
Healthy: Nicotine
n=10 participants at risk
Healthy controls will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task.
|
SCZ: Placebo
n=8 participants at risk
Subjects with schizophrenia (SCZ) will apply placebo skin patch for up to two hours prior to behavioral and EEG task.
|
SCZ: Nicotine
n=8 participants at risk
Subjects with schizophrenia (SCZ) will apply nicotine skin patch (7 mg/24 hour dose) for up to two hours prior to behavioral and EEG task.
|
|---|---|---|---|---|
|
Eye disorders
Blurry vision
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
30.0%
3/10 • Number of events 3 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
12.5%
1/8 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
12.5%
1/8 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
10.0%
1/10 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
20.0%
2/10 • Number of events 2 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Gastrointestinal disorders
Dry mouth
|
10.0%
1/10 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
10.0%
1/10 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
12.5%
1/8 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
20.0%
2/10 • Number of events 2 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
12.5%
1/8 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Gastrointestinal disorders
Increased salivation
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
12.5%
1/8 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
10.0%
1/10 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
12.5%
1/8 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Renal and urinary disorders
Increased urination
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
10.0%
1/10 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
|
Cardiac disorders
Heart palpitations
|
0.00%
0/10 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
10.0%
1/10 • Number of events 1 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
0.00%
0/8 • 30 minutes following removal of patch on each session day.
Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant using the Udvalg for Kliniske Undersøgelser (UKU) side effect rating scale autonomic subscale score. Adverse events were collected from the time the consent was signed through participant completion.
|
Additional Information
Alan S. Lewis, M.D., Ph.D.
Vanderbilt University Medical Center
Phone: 615-875-4027
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place