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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 the effects of alcohol. Secondary outcomes will include physiological effects, subjective- and observer-rated outcomes, and psychomotor performance under the various dose conditions.

Conditions

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

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40508
Contact:
Paul A. Nuzzo, M.A.
859-323-0002
paul.nuzzo@uky.edu

More Details

NCT ID
NCT03699540
Status
Recruiting
Sponsor
Shanna Babalonis, PhD

Study Contact

Shanna Babalonis, Ph.D.
(859) 257-1881
babalonis@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.