Actively Recruiting
The Impact of 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
17 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
Researchers are studying the effects of vaporized cannabis and alcohol co-use on cognitive and behavioral impairment. This study involves healthy adults who have experience using both substances and aims to understand how different doses of cannabis and alcohol, alone or combined, affect performance and subjective feelings. The study is conducted in a controlled laboratory environment and uses a randomized, double-blind design to compare different combinations of active and placebo cannabis and alcohol. Participants will complete seven outpatient sessions where they self-administer vaporized cannabis capsules containing 0, 5, or 25 mg of THC along with either a placebo or alcohol drink designed to reach a breath alcohol concentration (BAC) of 0.05%. One session will include a higher alcohol dose targeting a BAC of 0.08% as a positive control. Sessions are spaced at least 48 hours apart to allow drug washout and last about 8 hours each. Cannabis is vaporized using a handheld device called the Mighty Medic, and alcohol is ingested orally. During each session, participants undergo multiple assessments including blood collection, subjective questionnaires, cognitive performance tests, and simulated driving tasks. Researchers will measure impairment using tools such as the DRUID application, Paced Auditory Serial Addition Task, Digit Symbol Substitution Task, Field Sobriety Tests, and various subjective drug effect questionnaires. Safety, pharmacokinetics, and driving performance are monitored throughout. The total participation involves screening and up to seven experimental sessions conducted over several weeks.
CONDITIONS
Brief Title
Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have provided written informed consent
- Be at least 21 years of age
- Be in good general health based on a physical exam, medical history, vital signs, and screening urine and blood tests
- Not be pregnant or nursing (if female), with negative pregnancy tests at screening and each visit
- Have not donated blood in the prior 30 days
- Report at least one day of binge drinking in the past 3 months (more than 4 drinks for women, 5 for men)
- Report at least one use of cannabis in the past 3 years
- Provide negative urine test for illicit drugs (excluding THC) and negative breath alcohol test at screening and before sessions
- Report at least one lifetime instance of simultaneous alcohol and cannabis use
- Have no current prescription medication use that may interact with study drugs such as warfarin or cyclosporine
You will not qualify if you...
- Use of psychoactive drugs other than cannabis, nicotine, alcohol, or caffeine in the past month
- History or current evidence of significant medical conditions that increase risk
- Evidence of a current psychiatric condition
- Meet criteria for severe alcohol use disorder
- CIWA-Ar score greater than 9
- Use cannabis more than 3 days per week on average over past 3 months
- Enrolled in another clinical trial or received drug as part of research within past 30 days
- Shipley vocabulary score below 18 (equivalent to 5th grade reading level)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 5 weeks
Participants complete 7 experimental sessions in randomized order where they vaporize cannabis-containing capsules with either an alcohol or placebo drink. Each session lasts approximately 8 hours and is separated by at least 48 hours to allow for drug washout.
7 treatment visits (in-person), with up to 2 sessions per week
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
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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