Trial Outcomes & Findings for Eye Tracking as a Biomarker of Cannabis Effects (NCT NCT04100590)
NCT ID: NCT04100590
Last Updated: 2022-06-30
Results Overview
Using a Virtual Reality headset, a stimulus (a fixation cross) moves from 12 inches to 2 inches away from the participant's nose at a continuous speed over 5 seconds, then is held at that point for 10 seconds. The accuracy with which the participant completes this task will be measured by comparing pupil position with the target position within the virtual reality environment, down to the millimeter. Speed will also be assessed by measuring pupil position as a function of target fixation, down to the millisecond.
TERMINATED
PHASE2
1 participants
% Change from baseline during each of two sessions (measurements taken at baseline, 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis)
2022-06-30
Participant Flow
Participants are randomly assigned to receive active cannabis (7.0% THC) or placebo cannabis (0.0% THC) in a counterbalanced order.
The device used to collect eye-tracking data in this study did not properly detect any changes in eye behavior as a function of cannabis use, which is why the study was halted. Thus, no results are available.
Participant milestones
| Measure |
Cannabis
In this session, the participant will smoke two-thirds of one cannabis cigarette (7% THC or 0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.
Cannabis: Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)
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|---|---|
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Overall Study
STARTED
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1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Eye Tracking as a Biomarker of Cannabis Effects
Baseline characteristics by cohort
| Measure |
Cannabis
n=1 Participants
In this session, the participant will smoke two-thirds of one cannabis cigarette (7% THC or 0% THC) according to our paced-puff procedure (Foltin et al. 1987). They will complete an eye task battery (5 minutes per battery) 15 minutes prior to smoking as a baseline measure in each session, and again at the following timepoints: 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis. Baseline assessments will be compared to those at post-cannabis timepoints.
Cannabis: Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: % Change from baseline during each of two sessions (measurements taken at baseline, 0, 15, 30, 45, 60, 75, 90, 105, 120, and 165 minutes post-cannabis)Population: Data was not able to be collected from the device used for this study; thus, no data on convergence is available and the study was stopped.
Using a Virtual Reality headset, a stimulus (a fixation cross) moves from 12 inches to 2 inches away from the participant's nose at a continuous speed over 5 seconds, then is held at that point for 10 seconds. The accuracy with which the participant completes this task will be measured by comparing pupil position with the target position within the virtual reality environment, down to the millimeter. Speed will also be assessed by measuring pupil position as a function of target fixation, down to the millisecond.
Outcome measures
Outcome data not reported
Adverse Events
Active Cannabis
Inactive Cannabis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Caroline A Arout, PhD
New York State Psychiatric Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place