Trial Outcomes & Findings for Combined Alcohol and Cannabis Effects on Skills of Young Drivers (NCT NCT03106363)
NCT ID: NCT03106363
Last Updated: 2026-07-24
Results Overview
The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. Standard deviation of lateral position (SDLP) is a measure of lane control (higher SDLP indicates worse lane control).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
49 participants
Primary outcome timeframe
Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.
Results posted on
2026-07-24
Participant Flow
Interim analyses allowed us to check if stopping the trial was warranted, because it is not justified to keep going if there is an effect with a smaller sample size. The analysis was conducted with n = 28 participants and SDLP was used as the primary measure. It was determined that stopping the study at a smaller sample size was warranted as we were powered to see an effect with 27 participants. The study continued until 30 participants had completed all study procedures.
Participant milestones
| Measure |
Participant Group
All participants complete four sessions; order of sessions is randomized.
Placebo Alcohol/Placebo Cannabis session: Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (\< 0.03%) cigarette.
Alcohol/Placebo Cannabis session: Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (\< 0.03%) cigarette.
Placebo Alcohol/Cannabis session: Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
Alcohol/Cannabis session: Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
|
|---|---|
|
Overall Study
STARTED
|
49
|
|
Overall Study
Received placebo alcohol/placebo cannabis
|
38
|
|
Overall Study
Received active alcohol/placebo cannabis
|
40
|
|
Overall Study
Received placebo alcohol/active cannabis
|
41
|
|
Overall Study
Received active alcohol/active cannabis
|
40
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combined Alcohol and Cannabis Effects on Skills of Young Drivers
Baseline characteristics by cohort
| Measure |
Participant Group
n=28 Participants
Participants complete 4 sessions:
placebo alcohol/placebo cannabis alcohol/placebo cannabis placebo alcohol/cannabis alcohol/cannabis
|
|---|---|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 2.5 • n=9 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White European
|
10 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
East Asian
|
3 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
White North American
|
7 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
mixed heritage
|
3 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian-South
|
2 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Latin American
|
2 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian-South East
|
1 Participants
n=9 Participants
|
|
Body Mass Index
|
24.5 kg/m2
STANDARD_DEVIATION 3.4 • n=9 Participants
|
PRIMARY outcome
Timeframe: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. Standard deviation of lateral position (SDLP) is a measure of lane control (higher SDLP indicates worse lane control).
Outcome measures
| Measure |
Participant Group
n=28 Participants
Participants complete 4 sessions:
placebo alcohol/placebo cannabis alcohol/placebo cannabis placebo alcohol/cannabis alcohol/cannabis
|
|---|---|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Single Task - Placebo alcohol/placebo cannabis
|
0.30 meters
Standard Error 0.01
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Single Task - Active Alcohol/Placebo Cannabis
|
0.32 meters
Standard Error 0.01
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Single Task - Placebo Alcohol/Active Cannabis
|
0.33 meters
Standard Error 0.01
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Single Task - Active Alcohol/Active Cannabis
|
0.28 meters
Standard Error 0.01
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Dual Task - Placebo Alcohol/Placebo Cannabis
|
0.28 meters
Standard Error 0.01
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Dual Task - Active Alcohol/Placebo Cannabis
|
0.33 meters
Standard Error 0.01
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Dual Task - Placebo Alcohol/Active Cannabis
|
0.32 meters
Standard Error 0.02
|
|
Psychomotor Impairment: Standard Deviation of Lateral Position
Post-Drug Dual Task Active Alcohol/Active Cannabis
|
0.38 meters
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. Mean speed during the driving scenarios is measured by the simulator.
Outcome measures
| Measure |
Participant Group
n=28 Participants
Participants complete 4 sessions:
placebo alcohol/placebo cannabis alcohol/placebo cannabis placebo alcohol/cannabis alcohol/cannabis
|
|---|---|
|
Psychomotor Impairment: Mean Speed
Post-Drug Single Task - Placebo alcohol/placebo cannabis
|
84.07 km/h
Standard Error 0.84
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Single Task - Active Alcohol/Placebo Cannabis
|
85.06 km/h
Standard Error 1.38
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Single Task - Placebo Alcohol/Active Cannabis
|
83.27 km/h
Standard Error 0.78
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Single Task - Active Alcohol/Active Cannabis
|
84.64 km/h
Standard Error 1.82
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Dual Task - Placebo Alcohol/Placebo Cannabis
|
83.23 km/h
Standard Error 0.94
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Dual Task - Active Alcohol/Placebo Cannabis
|
87.34 km/h
Standard Error 2.10
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Dual Task - Placebo Alcohol/Active Cannabis
|
83.45 km/h
Standard Error 1.09
|
|
Psychomotor Impairment: Mean Speed
Post-Drug Dual Task Active Alcohol/Active Cannabis
|
85.25 km/h
Standard Error 2.27
|
SECONDARY outcome
Timeframe: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. The simulator also (in addition to mean speed) measures standard deviation of speed.
Outcome measures
| Measure |
Participant Group
n=28 Participants
Participants complete 4 sessions:
placebo alcohol/placebo cannabis alcohol/placebo cannabis placebo alcohol/cannabis alcohol/cannabis
|
|---|---|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Dual Task - Placebo Alcohol/Placebo Cannabis
|
4.92 km/h
Standard Error 0.29
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Single Task - Placebo alcohol/placebo cannabis
|
4.72 km/h
Standard Error 0.55
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Single Task - Active Alcohol/Placebo Cannabis
|
5.80 km/h
Standard Error 0.78
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Single Task - Placebo Alcohol/Active Cannabis
|
4.37 km/h
Standard Error 0.47
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Single Task - Active Alcohol/Active Cannabis
|
4.81 km/h
Standard Error 0.44
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Dual Task - Active Alcohol/Placebo Cannabis
|
6.38 km/h
Standard Error 0.59
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Dual Task - Placebo Alcohol/Active Cannabis
|
5.15 km/h
Standard Error 0.36
|
|
Psychomotor Impairment: Standard Deviation of Speed
Post-Drug Dual Task Active Alcohol/Active Cannabis
|
6.06 km/h
Standard Error 0.39
|
SECONDARY outcome
Timeframe: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur within 2 hours before and approximately 45 minutes after Time 0.]The driving simulator will objectively measure changes in driving behavior after alcohol and/or cannabis exposure. The simulator measures maximum speed over the duration of the scenarios.
Outcome measures
| Measure |
Participant Group
n=28 Participants
Participants complete 4 sessions:
placebo alcohol/placebo cannabis alcohol/placebo cannabis placebo alcohol/cannabis alcohol/cannabis
|
|---|---|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Single Task - Placebo alcohol/placebo cannabis
|
93.85 km/h
Standard Error 3.01
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Single Task - Active Alcohol/Placebo Cannabis
|
98.85 km/h
Standard Error 3.02
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Single Task - Placebo Alcohol/Active Cannabis
|
94.64 km/h
Standard Error 1.65
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Single Task - Active Alcohol/Active Cannabis
|
97.76 km/h
Standard Error 2.41
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Dual Task - Placebo Alcohol/Placebo Cannabis
|
95.84 km/h
Standard Error 1.43
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Dual Task - Active Alcohol/Placebo Cannabis
|
102.84 km/h
Standard Error 2.91
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Dual Task - Placebo Alcohol/Active Cannabis
|
97.04 km/h
Standard Error 1.73
|
|
Psychomotor Impairment: Maximum Speed
Post-Drug Dual Task Active Alcohol/Active Cannabis
|
101.08 km/h
Standard Error 2.68
|
SECONDARY outcome
Timeframe: Alcohol exposure is Time 0. Cannabis exposure follows 15 minutes after Time 0. Driving simulation tests occur at baseline and approximately 45 minutes after Time 0.The driving simulator objectively measures changes in driving behavior after alcohol and/or cannabis exposure. During specific reaction time scenarios, participants must stop as quickly as possible after certain visual cues. The brake latency variable is measured as the mean stop/reaction time in seconds after the visual cue is presented.
Outcome measures
| Measure |
Participant Group
n=28 Participants
Participants complete 4 sessions:
placebo alcohol/placebo cannabis alcohol/placebo cannabis placebo alcohol/cannabis alcohol/cannabis
|
|---|---|
|
Psychomotor Impairment: Brake Latency
Post-Drug Placebo alcohol/placebo cannabis
|
0.99 seconds
Standard Error 0.03
|
|
Psychomotor Impairment: Brake Latency
Post-Drug Active Alcohol/Placebo Cannabis
|
1.04 seconds
Standard Error 0.02
|
|
Psychomotor Impairment: Brake Latency
Post-Drug - Placebo Alcohol/Active Cannabis
|
0.99 seconds
Standard Error 0.03
|
|
Psychomotor Impairment: Brake Latency
Post-Drug - Active Alcohol/Active Cannabis
|
1.04 seconds
Standard Error 0.02
|
Adverse Events
Active Alcohol/Active Cannabis
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Placebo Alcohol/Active Cannabis
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Active Alcohol/Placebo Cannabis
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo Alcohol/Placebo Cannabis
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Alcohol/Active Cannabis
n=40 participants at risk
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
|
Placebo Alcohol/Active Cannabis
n=41 participants at risk
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a delta 9 tetrahydrocannabinol (potency 12.5%) cigarette.
|
Active Alcohol/Placebo Cannabis
n=40 participants at risk
Participant will drink an alcoholic beverage to obtain a target blood alcohol content of 0.08mg% and will smoke a placebo delta 9 tetrahydrocannabinol (\< 0.03%) cigarette.
|
Placebo Alcohol/Placebo Cannabis
n=38 participants at risk
Participant will drink tonic water (capped with a minimal amount of alcohol to enhance alcohol cues) and will smoke a placebo delta 9 tetrahydrocannabinol (\< 0.03%) cigarette.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain/Bruising at site of blood draw
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
4.9%
2/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
2.6%
1/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Skin and subcutaneous tissue disorders
Skin infection at site of blood draw
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
General disorders
Dizziness/Faintness
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
4.9%
2/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Cardiac disorders
Abormal vitals, pale skin
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
2.4%
1/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
General disorders
Headache
|
5.0%
2/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
General disorders
Memory effects
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
2.6%
1/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Skin and subcutaneous tissue disorders
Shingles infection
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Injury, poisoning and procedural complications
Finger fracture
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Infections and infestations
Common cold symptoms
|
7.5%
3/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
2.4%
1/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Reproductive system and breast disorders
Menstrual cramps
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Eye disorders
Bloodshot eyes
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Gastrointestinal disorders
Nausea/Vomiting
|
7.5%
3/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
12.5%
5/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
5.3%
2/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.5%
1/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/41 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/40 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
0.00%
0/38 • Collected from the first to the last testing session (i.e., approximately one month).
Participants were monitored for any adverse events (AEs) using a modified version of the Systematic Assessment for Treatment Emergent Effects (SAFTEE) questionnaire.
|
Additional Information
Dr. Christine Wickens
Centre for Addiction and Mental Health
Phone: 416-535-8501
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place