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Vaporized Cannabis Administration and Co-Administration of Alcohol on Impairment

NCT06293040 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-09-12

No results posted yet for this study

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

Interventions

DRUG

Cannabis

Cannabis will be vaporized using the Mighty Medic

DRUG

Alcohol

Alcohol will be orally ingested via a flavored drink

DRUG

Placebo Cannabis

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

DRUG

Placebo Alcohol

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

Sponsors & Collaborators

Principal Investigators

  • Tory Spindle, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-26
Primary Completion
2027-08-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06293040 on ClinicalTrials.gov