The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment

IRB00290015

This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.

2022-02-17

2025-05-01

2025-05-01

Recruiting

Early phase I

90

Inclusion Criteria: 1. Have provided written informed consent 2. Be between the ages of 21 and 55 3. Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests 4. 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. 5. Have a body mass index (BMI) in the range of 19 to 36 kg/m2 6. Blood pressure at Screening Visit does not exceed a systolic blood pressure (SBP) of 150 mmHg or a diastolic blood pressure (DBP) of 90 mmHg 7. Have not donated blood in the prior 30 days. 8. Report at least 2 days of binge drinking in the past 90 days (greater than 4 or 5 drinks on a single occasion for women and men, respectively) 9. Report ≥ 1 use of cannabis in the past year 10. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions 11. Report at least 1 instance of simultaneous alcohol and use in the past year. Exclusion Criteria: 1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month 2. Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigator or medical staff, will impact the participant's safety 3. History of or current evidence of significant medical condition 4. Evidence of current psychiatric condition \[(MINI for Diagnostic and Statistical Manual (DSM)-V)\] 5. Meet criteria for severe alcohol use disorder (MINI for DSM-V) 6. Clinical Institute Withdrawal Assessment for Alcohol scale (CIWA-Ar) score \> 9 7. Been in treatment previously for alcohol or cannabis use disorder 8. Use of cannabis, on average, more than 2 times/week over past 3 months 9. Liver function tests more than 2x normal range 10. Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days 11. Shipley vocabulary score \<18 (corresponds to 5th grade reading level).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'All participants will complete all dose conditions (study arms) in a randomized order', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double-blind (Participant, Outcomes Assessor), placebo controlled, and double-dummy', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2024-03-19