Cannabis Consumption for Driving Impairment

Overseen By Dario L Sacchi, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Bayliss J. Camp, PhD

Disqualifiers: Pregnancy, DUI, Parole, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

300 Participants Needed

Trial Summary

What is the purpose of this trial?

In a true experiment, roughly 300 volunteer participants will smoke active cannabis, a corresponding placebo, or no substance at all (control). Next, participants will complete a drive test and then be observed by actual California Highway Patrol (CHP) officers who will attempt to classify participants as impaired or unimpaired. CHP Officers will evaluate participants in the context of driving (i.e., while following participants in an actual patrol car), as part of a roadside behavioral assessment (i.e., the Advanced Roadside Impaired Driving Enforcement, or ARIDE, battery, which includes Standardized Field Sobriety Tests, or SFSTs), and as part of a Drug Recognition Expert (DRE) evaluation conducted indoors.

Research Team

Bayliss J Camp, PhD

Principal Investigator

California Department of Motor Vehicles

Eligibility Criteria

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.

Inclusion Criteria

You have consumed cannabis in the past six months.

You are committed to refraining from alcohol, cannabis and other intoxicants for a 24 hour period before participating.

You possess a valid driver's license issued by the state of California.

Exclusion Criteria

I am not willing to travel by taxi.

Parole or probation status

Completion of a roadside sobriety test during the previous 12 months

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either active cannabis, placebo cannabis, or no substance at all

1 day

1 visit (in-person)

Assessment

Participants undergo driving tests and evaluations by CHP officers, including ARIDE and DRE evaluations

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

Treatment Details

Interventions

• Active smoked cannabis
• Placebo smoked cannabis

Trial Overview 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.

Participant Groups

Group I: Active Smoked Cannabis Experimental Treatment 1 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: Control Active Control 1 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 Cannabis Placebo Group 1 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.

Who Is Running the Clinical Trial?

Bayliss J. Camp, PhD

Lead Sponsor

Trials

1

Recruited

300+