Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

Launched by JOHNS HOPKINS UNIVERSITY · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how using vaporized cannabis and alcohol together affects a person’s ability to think and react. Researchers want to understand how these substances impair cognitive function, which means how well someone can think, learn, and remember. The study involves 32 participants who will attend seven sessions where they will either use a placebo (non-active) or active vaporized cannabis and drink either a non-alcoholic beverage or a drink that contains alcohol. Some sessions will also include a higher alcohol level to see how it impacts impairment.

To join the study, participants must be at least 21 years old, in good health, and have a history of both binge drinking and cannabis use. Women must not be pregnant or nursing and will need to take pregnancy tests during the study. Participants will be closely monitored and will undergo various tests to ensure they are safe to participate. This study is important for understanding how these substances can affect people, especially in situations like driving, where clear thinking is crucial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Have provided written informed consent
• • 2. Be at least 21 years of age
• • 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 not donated blood in the prior 30 days
• • 6. 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)
• • 7. Report at least 1 use of cannabis in the past 3 years
• • 8. Provide negative urine test for illicit drug use (excluding THC) and negative breath alcohol test (0% BAC) at screening and before study sessions
• • 9. Report at least 1 lifetime instance of simultaneous alcohol and cannabis use
• • 10. Current concomitant prescription medication use that may interact with the investigational study drug, including inhibitors and inducers of CYP2CP and CYP3A4 as well as highly-protein bound drugs and drugs with a narrow therapeutic index such as warfarin, cyclosporine, and amphotericin B
• Exclusion Criteria:
• • 1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month
• • 2. History of or current evidence of significant medical condition that would put the participant at risk
• • 3. Evidence of current psychiatric condition (MINI for DSM-V)
• • 4. Meet criteria for severe alcohol use disorder (MINI for DSM-V)
• • 5. CIWA-Ar score \> 9
• • 6. Use of cannabis, on average, more than 3 days/week over past 3 months
• • 7. Enrollment in another clinical trial or receiving of any drug as part of research within past 30 days
• • 8. Shipley vocabulary score \<18 (corresponds to 5th grade reading level)