CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 199 enrolled
Drug / intervention
Cannabisdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02849587
NCT02849587Phase 2Completed

A Randomized, Controlled Trial of Cannabis in Healthy Volunteers Evaluating Simulated Driving, Field Performance Tests and Cannabinoid Levels

University of California, San Diego·interventional·Posted Jul 29, 2016·Updated Jan 4, 2022

In Brief

A Phase 2 clinical trial evaluating Cannabis for Cannabis Intoxication. Completed, enrolled 199 participants across 1 site.

Detailed Summary

This study was authorized by the California Legislature (Assembly Bill 266, the Medical Marijuana Regulation and Safety Act to help with detection of driving under the influence of cannabis. One hundred and eighty healthy volunteers will inhale smoked cannabis with either 0% (placebo), 5.9%, or 13.4% Δ9-tetrahydrocannabinol (THC) at the beginning of the day, and then complete driving simulations, iPad-based performance assessments, and bodily fluid draws (e.g., blood, saliva, breath) before the cannabis smoking and a number of times over the subsequent 6 hours after cannabis smoking. The purpose is to determine (1) the relationship of the dose of Δ9-THC on driving performance and (2) the duration of driving impairment in terms of hours from initial use, (3) if saliva or expired air can serve as a useful substitute for blood sampling of Δ9-THC, and (4) if testing using an iPad can serve as a useful adjunct to the standardized field sobriety test in identifying acute impairment from cannabis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJul 29, 2016
Enrollment StartFeb 24, 2017
Primary CompletionJun 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.9 years ago

Interventions

Cannabisdrug

Participants will smoke a cannabis cigarette ad libitum as per their usual routine