Marijuana Effects on Simulated Driving Performance

Shanna Babalonis, PhD

Status and phase: Completed; Phase 1

Conditions: Cannabis; Marijuana Usage; Cannabis Use; Alcohol Drinking; Marijuana

Treatments: Drug: Inactive marijuana; Drug: Alcohol; Drug: Marijuana; Drug: placebo alcohol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03699540

43636

R21DA045101-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 21 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

10 participants in 4 patient groups, including a placebo group

Active Marijuana Dose

Experimental group

Description:

Participants will receive experimental/non-therapeutic dose(s) of active marijuana, under double-blind conditions

Treatment:

Drug: Marijuana

Inactive Marijuana Dose

Placebo Comparator group

Description:

Participants will receive experimental/non-therapeutic dose(s) of inactive marijuana, under double-blind conditions

Treatment:

Drug: Inactive marijuana

Active Alcohol Dose

Active Comparator group

Description:

Participants will receive experimental/non-therapeutic dose(s) of active alcohol, under double-blind conditions

Treatment:

Drug: Alcohol

Inactive Alcohol Dose

Placebo Comparator group

Description:

Participants will receive experimental/non-therapeutic dose(s) of inactive alcohol, under double-blind conditions

Treatment:

Drug: placebo alcohol