Recruiting
Phase 1

Vaporized Cannabis & Alcohol

Sponsor:

Johns Hopkins University

Code:

NCT06293040

Conditions

Cannabis Intoxication

Alcohol Intoxication

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Cannabis

Alcohol

Placebo Cannabis

Placebo Alcohol

Study Details

Brief summary:

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

Cannabis Intoxication

Alcohol Intoxication

Study ID

NCT06293040

Start date

Sep 26, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo cannabis + placebo alcohol

Participants administer vaporized cannabis containing 0mg THC in combination with a placebo alcohol drink.

experimental: Low dose cannabis with placebo alcohol

Participants administer vaporized cannabis containing 5mg THC in combination with a placebo alcohol drink.

experimental: High dose cannabis with placebo alcohol

Participants administer vaporized cannabis containing 25mg THC in combination with a placebo alcohol drink.

experimental: Low dose cannabis with low dose alcohol

Participants administer vaporized cannabis containing 5mg THC in combination with an alcohol drink (0.05 percent BAC).

experimental: High dose cannabis with low dose alcohol

Participants administer vaporized cannabis containing 25mg THC in combination with an alcohol drink (0.05 percent BAC).

experimental: Placebo cannabis + low dose alcohol

Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.05 percent BAC).

experimental: Placebo cannabis + high dose alcohol

Participants administer vaporized cannabis containing 0mg THC in combination with an alcohol drink (0.08 percent BAC).

Interventions

Cannabis

Cannabis will be vaporized using the Mighty Medic

Alcohol

Alcohol will be orally ingested via a flavored drink

Placebo Cannabis

Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.

Placebo Alcohol

A non-alcoholic, placebo, flavored drink will be orally ingested.

Primary outcome measure

  • DRUID application global impairment score [ Time Frame: Up to 6 hours ]
  • Correct Trials on Paced Auditory Serial Addition Task (PASAT) [ Time Frame: Up to 6 hours ]
  • Correct Trials on the Digit Symbol Substitution Task (DSST) [ Time Frame: Up to 6 hours ]
  • Cumulative score on Field Sobriety Tests [ Time Frame: Up to 6 hours ]
  • Drug Effect Questionnaire (DEQ) - Feel Drug Effect [ Time Frame: Up to 6 hours ]
  • Drug Effect Questionnaire (DEQ) - Feel High [ Time Frame: Up to 6 hours ]
  • Drug Effect Questionnaire (DEQ) - Confidence to Drive [ Time Frame: Up to 6 hours ]
  • Drug Effect Questionnaire (DEQ) - Willingness to Drive [ Time Frame: Up to 6 hours ]
  • Biphasic alcohol effects scale (BAES) - Sedative Score [ Time Frame: Up to 6 hours ]
  • Biphasic alcohol effects scale (BAES) - Stimulant Score [ Time Frame: Up to 6 hours ]
  • Subjective high assessment scale (SHAS) [ Time Frame: Up to 6 hours ]
  • Driving performance as assessed by standard deviation of lateral position (SDLP) [ Time Frame: Up to 6 hours ]
  • Driving performance as assessed by composite drive score [ Time Frame: Up to 6 hours ]

Central Contacts and Locations

Central contacts

Locations

Johns Hopkins Behavioral Pharmacology Research Unit

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Anna Kohler

akohler3@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-09-08.