NCT04931095

The Impact of Oral Cannabis Administration and Co-Administration of Alcohol on Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the individual and interactive effects of oral cannabis and alcohol on subjective and behavioral measures of impairment.

Detailed description

This clinical laboratory study will be double-blind, placebo-controlled and will utilize a within-subjects experimental design. Participants will complete 7 outpatient drug administration sessions that will consist of self-administration of oral cannabis (0, 10 or 25mg THC) and alcohol (either placebo or active; BAC of 0.05 percent); participants will always receive both an alcohol drink (active or placebo) and dose of cannabis (active or placebo). Participants will also complete a condition in which they administer alcohol (BAC: 0.08 percent) with placebo cannabis, as a positive control. Primary outcomes include performance on field sobriety tests, cognitive and psychomotor impairment, subjective drug effects, and simulated driving performance. Blood concentrations of THC and THC metabolites will also be determined.

Conditions

• Cannabis Intoxication
• Alcohol Intoxication

Interventions

Type	Name	Description
DRUG	Cannabis	Cannabis will be orally ingested via a brownie
DRUG	Alcohol	Alcohol will be orally ingested via a flavored drink

Timeline

• Start date: 2022-02-17
• Primary completion: 2025-08-15
• Completion: 2025-08-15
• First posted: 2021-06-18
• Last updated: 2025-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study