Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment (NCT06293040) | Clinical Trial Compass
RecruitingPhase 1
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
United States90 participantsStarted 2024-09-26
Plain-language summary
This human laboratory study will use cognitive, behavioral, and subjective measures to characterize impairment associated with co-use of alcohol and vaporized cannabis. Participants (n=32) will complete 7 double-blind, double-dummy outpatient sessions in randomized order. In each session, participants will self-administer placebo (0 mg THC) or active vaporized cannabis (5 or 25 mg THC, via a handheld vaporizer called the Mighty Medic) and a placebo drink (BAC 0.0%) or alcohol drink calculated to produce a breath alcohol concentration (BAC) of 0.05%. Participants will also complete a positive control session in which the participant administers placebo cannabis and alcohol at a target BAC of 0.08% (the legal threshold for driving impairment in most U.S. states).
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Have provided written informed consent
✓. Be at least 21 years of age
✓. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests
✓. Not be pregnant or nursing (if female). All females must have a negative serum pregnancy test at the screening visit and a negative urine pregnancy test at each study visit
✓. Have not donated blood in the prior 30 days
✓. Report at least 1 day of binge drinking in the past 3 months (greater than 4 or 5 drinks on a single occasion for women and men, respectively)
✓. Report at least 1 use of cannabis in the past 3 years
✓. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
Exclusion criteria
✕. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
What they're measuring
1
DRUID application global impairment score
Timeframe: Up to 6 hours
2
Correct Trials on Paced Auditory Serial Addition Task (PASAT)
Timeframe: Up to 6 hours
3
Correct Trials on the Digit Symbol Substitution Task (DSST)
Timeframe: Up to 6 hours
4
Cumulative score on Field Sobriety Tests
Timeframe: Up to 6 hours
5
Drug Effect Questionnaire (DEQ) - Feel Drug Effect
Timeframe: Up to 6 hours
6
Drug Effect Questionnaire (DEQ) - Feel High
Timeframe: Up to 6 hours
7
Drug Effect Questionnaire (DEQ) - Confidence to Drive
Timeframe: Up to 6 hours
8
Drug Effect Questionnaire (DEQ) - Willingness to Drive