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Completed

NCT Number: NCT03699540

Marijuana Effects on Simulated Driving Performance

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.

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Key information

Conditions

Cannabis Alcohol Drinking Behavior Cannabis Use Chemically-Induced Disorders Drinking Behavior Marijuana Marijuana Abuse Marijuana Usage Mental Disorders Substance-Related Disorders

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40508, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Marijuana

Drug

Experimental, non-therapeutic administration of active marijuana dose(s)

Other names: Active cannabis

Alcohol

Drug

Experimental, non-therapeutic administration of active alcohol dose(s)

Other names: Active alcohol

placebo alcohol

Drug

Experimental, non-therapeutic administration of inactive alcohol dose(s)

Inactive marijuana

Drug

Experimental, non-therapeutic administration of inactive marijuana dose(s)

Other names: inactive cannabis

Primary outcomes

  1. Mean Peak for Standard Deviation in Lane Position (SDLP)

    Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

    Standard deviation of lane position (SDLP) of the car is the amount of weaving/swerving of the car in and out of the lane. It is a frequent metric for assessing driving ability.

Secondary outcomes

  1. Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty

    Time frame: This outcome (VAS score) was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

    Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate worse outcome/greater impairment. Raw data transformed to peak scores.

  2. Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect

    Time frame: This outcome (VAS scores) was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 9 hrs)

    Participants rated their subjective response on a standardized VAS scale (0 to 100). Higher scores indicate greater drug effects. Raw data transformed to peak scores.

  3. Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating

    Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

    Participants rated their subjective response on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.

  4. Observer-Rated Outcome: Mean Peak Score for Relaxed

    Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

    Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.

  5. Observer-Rated Outcome: Mean Peak Score for Good Mood

    Time frame: This outcome was recorded in regular intervals after drug administration for the duration of the session (approx. 9 hrs) and a peak score was calculated across all these time intervals.

    Research observer rated on a Likert type scale (Not at all=0, A Little Bit=1, Moderately=2, Quite A Bit=3, Extremely=4). Greater values indicate greater drug effect. Raw data transformed to peak scores.

Sponsors and collaborators

Lead sponsor

Shanna Babalonis, PhD

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 9, 2018
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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