Effects of vaporized cannabis and alcohol on impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This human laboratory study aims to characterize the impairment associated with the co-use of alcohol and vaporized cannabis. A total of 32 participants will undergo 7 double-blind, double-dummy outpatient sessions where they will self-administer either placebo or active vaporized cannabis at varying THC doses alongside either a placebo or alcohol drink designed to achieve a specific breath alcohol concentration. The study will also include a positive control session to assess impairment at a legal driving limit. Various cognitive, behavioral, and subjective measures will be collected throughout the sessions to evaluate the effects of these substances on impairment.

Why it matters

Who can join: the full rules

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)

Where it's running

• Johns Hopkins Behavioral Pharmacology Research Unit
  Baltimore, Maryland, United States Recruiting

Study contacts

• Principal investigator: Tory Spindle, PhD — Johns Hopkins University
• Study coordinator: Tory Spindle, PhD
• Email: tspindle@jhmi.edu
• Phone: 410-550-0529

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.