Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06293040
Phase
PHASE1
Status
Recruiting
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Conditions

  • Alcohol Intoxication
  • Cannabis Intoxication

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cannabis — DRUG
    Cannabis will be vaporized using the Mighty Medic
  • Alcohol — DRUG
    Alcohol will be orally ingested via a flavored drink
  • Placebo Cannabis — DRUG
    Placebo cannabis (i.e., water vapor) will be vaporized using the Mighty Medic.
  • Placebo Alcohol — DRUG
    A non-alcoholic, placebo, flavored drink will be orally ingested.

Study Details

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).

Key Dates

Start date
Sep 26, 2024
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

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).

Primary Outcome Measure

DRUID application global impairment score [ Time Frame: Up to 6 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Behavioral Pharmacology Research UnitBaltimoreMaryland21224

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