Trial Outcomes & Findings for Marijuana Effects on Simulated Driving Performance (NCT NCT03699540)

Last Updated: 2024-07-31

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

10 participants

Primary outcome timeframe

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.

Results posted on

2024-07-31

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	Marijuana Effects on Simulated Driving Performance Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active alcohol.
Overall Study STARTED	10
Overall Study Inactive Alcohol/ Tetrahydrocannabinol (THC) 0mg	8
Overall Study Inactive Alcohol/THC 15mg	10
Overall Study Inactive Alcohol/THC 30mg	9
Overall Study Inactive Alcohol/Combined THC 15mg/CBD 7.5mg	9
Overall Study Active Alcohol/THC 0mg	10
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Marijuana Effects on Simulated Driving Performance Within subject study. Participants will receive experimental/non-therapeutic doses of active/inactive marijuana in combination experimental/non-therapeutic dose of inactive/active alcohol.
Overall Study Lost to Follow-up	1

Baseline Characteristics

Marijuana Effects on Simulated Driving Performance

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Completing Participants n=9 Participants Subjects who completed the study
Age, Continuous	32.56 years STANDARD_DEVIATION 9.58 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.