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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

Must not have

Physical or psychological conditions that can be exacerbated by cannabis use, or for which cannabis use is contraindicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up conducted 15 minutes before the assigned intervention.

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.

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.

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

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I can avoid driving or using heavy machinery for 4 hours after my participation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have conditions worsened by cannabis or advised against its use.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ conducted immediately after the assigned intervention is completed.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Advanced Roadside Impaired Driving Enforcement (ARIDE) battery

Drug Recognition Expert (DRE) evaluation

Modified Driving Performance Examination (MDPE)

Secondary study objectives

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.

0 / 2Eligibility criteria met