Marijuana Effects on Simulated Driving Performance

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03699540

Enrollment

Registered

2018-10-09

Start date

2019-07-01

Completion date

2023-01-01

Last updated

2024-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Cannabis, Cannabis Use, Marijuana, Marijuana Usage

Keywords

simulated driving, outpatient

Brief summary

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.

Interventions

DRUGMarijuana

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

DRUGAlcohol

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

DRUGplacebo alcohol

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

DRUGInactive marijuana

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Masking description

Double-blind, double-dummy, placebo-controlled design

Intervention model description

Within-subject, randomized, placebo-controlled, double-dummy, double-blind study

Eligibility

Sex/Gender

ALL

Age

21 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Mean Peak for Standard Deviation in Lane Position (SDLP)	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

Measure	Time frame	Description
Subject-Rated Outcomes: Mean Peak Score for Driving Difficulty	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.
Subject-Rated Outcome: Mean Peak Score for Drug and Alcohol Effect	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.
Subject-Rated Outcome: Mean Peak Score for Difficulty Concentrating	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.
Observer-Rated Outcome: Mean Peak Score for Relaxed	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.
Observer-Rated Outcome: Mean Peak Score for Good Mood	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.

Countries

United States

Participant flow

Recruitment details

Participants were recruited via internet postings (e.g., Craigslist) and locally posted flyers.

Pre-assignment details

Participants meeting all I/E criteria were invited to enroll. Unique, randomized dose orders were created for each participant. The study utilized a within-subject, randomized, placebo-controlled, double-dummy, double-blind design.

Participants by arm

Arm	Count
Completing Participants Subjects who completed the study	9
Total	9

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Completing Participants
Age, Continuous	32.56 years STANDARD_DEVIATION 9.58
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	6 Participants
Region of Enrollment United States	9 participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	8 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk
deaths Total, all-cause mortality	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9
other Total, other adverse events	1 / 9	1 / 9	2 / 9	1 / 9	3 / 9
serious Total, serious adverse events	0 / 9	0 / 9	0 / 9	0 / 9	0 / 9

Outcome results

Primary

Mean Peak for Standard Deviation in Lane Position (SDLP)

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.

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.