Actively Recruiting
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Led by Johns Hopkins University · Updated on 2025-09-12
90
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
Sponsors
J
Johns Hopkins University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- At least 21 years of age
- In good general health based on physical exam, medical history, vital signs, and screening urine and blood tests
- Not pregnant or nursing (if female); negative serum pregnancy test at screening and negative urine pregnancy test at each study visit
- No blood donation in prior 30 days
- At least 1 day of binge drinking in past 3 months (more than 4 drinks for women or 5 drinks for men on a single occasion)
- At least 1 use of cannabis in past 3 years
- Negative urine test for illicit drugs (excluding THC) and negative breath alcohol test (0% BAC) at screening and before sessions
- At least 1 lifetime instance of simultaneous alcohol and cannabis use
- No current prescription medications that may interact with study drugs, including CYP2CP and CYP3A4 inhibitors/inducers and drugs with narrow therapeutic index
You will not qualify if you...
- Use of psychoactive drugs (other than cannabis, nicotine, alcohol, or caffeine) in past month
- History or current significant medical condition that increases risk
- Current psychiatric condition
- Severe alcohol use disorder
- CIWA-Ar score greater than 9
- Cannabis use more than 3 days per week on average in past 3 months
- Enrollment in another clinical trial or receipt of research drug in past 30 days
- Shipley vocabulary score less than 18 (below 5th grade reading level)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Johns Hopkins Behavioral Pharmacology Research Unit
Baltimore, Maryland, United States, 21224
Actively Recruiting
Research Team
T
Tory Spindle, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
7
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