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Cannabis Consumption for Driving Impairment

Phase 2
Recruiting
Led By Bayliss J Camp, PhD
Research Sponsored by Bayliss J. Camp, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Willing and able to avoid driving and operating heavy machinery for at least four hours after participation
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up conducted 15 minutes before the assigned intervention.
Awards & highlights

Study Summary

This trial will test whether smoking cannabis impairs driving ability. 300 volunteers will smoke cannabis, placebo, or no substance, then drive and be evaluated by CHP officers to measure impairment.

Who is the study for?
This trial is for adults who've used cannabis in the last six months, have a valid California driver's license, and live close to the study site. They must not use alcohol or drugs for 24 hours before participating and can't drive afterwards for four hours. People with recent DUIs, on parole/probation, or with certain health conditions are excluded.Check my eligibility
What is being tested?
The study tests how smoking actual cannabis versus a placebo affects driving ability. About 300 participants will be observed by police officers after completing a closed-course driving test to determine if they appear impaired using various roadside assessments.See study design
What are the potential side effects?
Since active cannabis is being tested against a placebo, side effects may include typical reactions to marijuana such as altered senses and mood changes, difficulty with thinking and problem-solving, impaired memory and body movement, hallucinations (when taken in high doses), delusions (with high doses), psychosis risk (especially in regular users).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can avoid driving or using heavy machinery for 4 hours after my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~conducted immediately after the assigned intervention is completed.
This trial's timeline: 3 weeks for screening, Varies for treatment, and conducted immediately after the assigned intervention is completed. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Advanced Roadside Impaired Driving Enforcement (ARIDE) battery
Drug Recognition Expert (DRE) evaluation
Modified Driving Performance Examination (MDPE)
Secondary outcome measures
First blood draw (baseline)
Second blood draw (change from baseline)
Third blood draw (change from baseline and second blood draw)

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Active Smoked CannabisExperimental Treatment1 Intervention
Participants in this arm will smoke an active cannabis cigarette containing 18.16% Δ9-tetrahydrocannabinol (THC). The smoking will occur at each participant's preferred pace, but will be limited to a maximum ten-minute period. While individual doses vary in this type of paradigm (ad libitum dosing), the anticipated dose of THC within the cannabis condition can be approximated by the following formula: (700 mg of cannabis) x [% of cigarette smoked; maximum of 70% (allowing room to hold the cigarette)] x (% THC). Therefore, the maximum dose in this arm is 700 mg x 70% x 18.2% = 89.18 mg of THC. Individual participants will only take part in the study under a single condition and receive the active cannabis once. Bulk cannabis for this arm will be provided by the National Institute on Drug Abuse Drug Supply Program; cannabis cigarettes will be prepared and prescribed by the Research Pharmacy of the University of California, San Diego.
Group II: ControlActive Control1 Intervention
Participants in this arm receive no cannabis. Individual participants will only take part in the study under a single condition.
Group III: Placebo Smoked CannabisPlacebo Group1 Intervention
Participants in this arm will smoke a placebo cannabis cigarette containing <.01 THC. The smoking will occur at each participant's preferred pace, but will be limited to a maximum ten-minute period. Individual participants will only take part in the study under a single condition and receive the placebo cannabis once. Bulk placebo for this arm will be provided by the National Institute on Drug Abuse Drug Supply Program; placebo cannabis cigarettes will be prepared and prescribed by the Research Pharmacy of the University of California, San Diego.

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Who is running the clinical trial?

Bayliss J. Camp, PhDLead Sponsor
Bayliss J Camp, PhDPrincipal InvestigatorCalifornia Department of Motor Vehicles

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the research study extend to those of an advanced age?

"Eligible candidates for this medical test must have passed their majority and not yet reached 55 years of age."

Answered by AI

Is it possible for me to register in this clinical experiment?

"This trial seeks 300 volunteers aged 21-55 with demonstrated cannabis use in the last half-year."

Answered by AI

Can one assume security when consuming Active Smoked Cannabis?

"Taking into account the existing data, our team at Power concluded that Active Smoked Cannabis is a safety rating of 2 on a 1 to 3 scale. This is because Phase 2 clinical trials have been conducted but no evidence has yet emerged demonstrating efficacy."

Answered by AI

What is the upper limit of participants for this medical experiment?

"Affirmative. Information hosted on clinicaltrials.gov confirms that this experiment is actively recruiting participants, having been initially posted on October 3rd 2023 and updated as recently as September 26th 2023. This trial needs to enrol 300 patients from 1 medical facility."

Answered by AI

Are there any vacancies left in this trial for participants?

"As per clinicaltrials.gov, this research is actively recruiting volunteers; it was initially posted on the 3rd of October 2023 and has most recently been revised on September 26th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
California Department of Motor Vehicles Headquarters
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I use cannabis regularly in conjunction with my prescriptions. I feel that it does not negatively impact my driving, but I would like to help keep the roads safe by contributing to this study.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Cannabis Consumption and Driving Impairment Assessment on a Closed Course
Bayliss J. Camp, PhD 2023. "Cannabis Consumption and Driving Impairment Assessment on a Closed Course". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059677.
~171 spots leftby Dec 2024
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