Marijuana Effects on Simulated Driving Performance

Purpose

This study will examine the effects of various strains of marijuana on simulated driving performance; the effects of alcohol administration will also be examined to further understand how marijuana-induced driving changes compare to the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

Conditions

  • Cannabis
  • Cannabis Use
  • Marijuana
  • Marijuana Usage
  • Alcohol Drinking

Eligibility

Eligible Ages
Between 21 Years and 50 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy, adult participants - Ages 21-50 - History of marijuana use - History of alcohol use

Exclusion Criteria

  • Clinically significant medical conditions - Ongoing/significant drug use outside of marijuana and alcohol use

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Intervention Model Description
Within-subject, randomized, placebo-controlled, double-dummy, double-blind study
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)
Masking Description
Double-blind, double-dummy, placebo-controlled design

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active Marijuana Dose 		Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions
  • Drug: Marijuana
    Experimental, non-therapeutic administration of active marijuana dose(s)
    Other names:
    • Active cannabis
Placebo Comparator
Inactive Marijuana Dose 		Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions
  • Drug: Inactive marijuana
    Experimental, non-therapeutic administration of inactive marijuana dose(s)
    Other names:
    • inactive cannabis
Active Comparator
Active Alcohol Dose 		Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions
  • Drug: Alcohol
    Experimental, non-therapeutic administration of active alcohol dose(s)
    Other names:
    • Active alcohol
Placebo Comparator
Inactive Alcohol Dose 		Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions
  • Drug: placebo alcohol
    Experimental, non-therapeutic administration of inactive alcohol dose(s)

Recruiting Locations

More Details

NCT ID
NCT03699540
Status
Completed
Sponsor
Shanna Babalonis, PhD