Cannabis Consumption and Driving Impairment Assessment on a Closed Course

NCT06059677 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 19C066000
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cannabis Smoking; Driving Impaired

Outcome Measures

Primary Outcomes (3)

• Modified Driving Performance Examination (MDPE)

  The MDPE driving test, developed for this study, is administered once per participant per experimental session. It occurs after the assigned intervention (i.e., drug administration) and it is primarily scored dichotomously (pass versus fail).

  Conducted an average of 35 minutes after the assigned intervention is completed.

• Advanced Roadside Impaired Driving Enforcement (ARIDE) battery

  The ARIDE battery is not a scale but a series of roadside behavioral assessments used by law enforcement officers to help them detect impaired driving: (1) pulse check, (2) Horizontal Gaze Nystagmus or HGN, (3) a test of distinct and sustained nystagmus, (4) vertical nystagmus, (5) lack of convergence test, (6) a check to see if eyes are bloodshot or watery, (7) Modified Romberg Balance Test, (8) Walk and Turn Test or WAT, (9) One Leg Stand Test or OLS, and some additional observations. The ARIDE battery occurs once per participant following the Modified Driving Performance Examination. The ARIDE battery is scored overall as pass versus fail by the officer conducting the test (in real-time).

  Conducted an average of 65 minutes after the assigned intervention is completed.

• Drug Recognition Expert (DRE) evaluation

  The DRE evaluation is designed to help law enforcement officers identify whether an individual is generally impaired and, if so, which class of substance caused the impairment. The DRE evaluation occurs once per participant, following the ARIDE battery. It is scored by the officer conducting it in real-time as a judgment about state of impairment (impaired versus unimpaired), and, in the case of impairment, a judgment about the class of substance.

  Conducted an average of 90 minutes after the assigned intervention is completed.

Secondary Outcomes (3)

• First blood draw (baseline)

  Conducted 15 minutes before the assigned intervention.

• Second blood draw (change from baseline)

  Conducted immediately after the assigned intervention is completed.

• Third blood draw (change from baseline and second blood draw)

  Conducted an average of 85 minutes after the assigned intervention is completed.

Study Arms (3)

Active Smoked Cannabis

EXPERIMENTAL

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.

Drug: Active smoked cannabis

Placebo Smoked Cannabis

PLACEBO COMPARATOR

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.

Drug: Placebo smoked cannabis

Control

NO INTERVENTION

Participants in this arm receive no cannabis. Individual participants will only take part in the study under a single condition.

Interventions

Active smoked cannabis DRUG

Assessment of active cannabis smoking and driving impairment

Also known as: marijuana, cannabis sativa, C. sativa L., C. sativa. Cannabis sativa L., Cannabis indica, C. indica

Active Smoked Cannabis

Placebo smoked cannabis DRUG

Assessment of placebo cannabis smoking and driving impairment

Also known as: marijuana placebo, cannabis placebo, placebo marijuana, placebo cannabis

Placebo Smoked Cannabis

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Possessing a valid California driver's license
• Cannabis use in the past six months
• Willing and able to abstain from alcohol, cannabis, and other recreational drugs for 24 hours prior to scheduled participation
• Willing and able to avoid driving and operating heavy machinery for at least four hours after participation
• Residence within approximately 15 miles of the study site
• Possessing the capacity to provide informed consent

You may not qualify if:

• Completion of a roadside sobriety test during the previous 12 months
• Physical or psychological conditions that can be exacerbated by cannabis use, or for which cannabis use is contraindicated
• Potential presence of Cannabis Use Disorder as assessed by a modified version of the Cannabis Use Disorder Identification Test
• Potential presence of Substance Use Disorder as assessed by a modified version of the Drug Abuse Screening Test
• Pregnancy or breastfeeding reported
• Unwillingness to be transported by taxi
• Having been convicted of Driving Under the Influence (DUI) within five years prior to scheduled participation
• Parole or probation status
• One or more felony convictions on record involving aggressive or dangerous criminal activity
• Any of the following at the time of the experimental session: breath alcohol content of .01% or greater; positive pregnancy test; cannabis consumption considered unsafe following medical checkup by the study nurse; or driving test behavior considered hazardous by the driving examiner

Sponsors & Collaborators

• Bayliss J. Camp, PhD: lead

Study Sites (1)

California Department of Motor Vehicles Headquarters

Sacramento, California, 95818-2606, United States

RECRUITING

MeSH Terms

Conditions

Marijuana Smoking

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Marijuana Use; Behavior; Smoking, Non-Tobacco Products; Smoking

Study Officials

• Bayliss J Camp, PhD

  California Department of Motor Vehicles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dario LM Sacchi, PhD

CONTACT

(916) 818 5312; dario.sacchi2@dmv.ca.gov

Dario L Sacchi, PhD

CONTACT

(916) 914 8118; Dario.Sacchi2@dmv.ca.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are blind to condition assignment, meaning they are not told in advance which version of the procedure they will experience. While those assigned to the true control condition will obviously realize this during the session, remaining participants are not informed whether the cigarette they smoke contains active cannabis or placebo. Similarly, the experimenters will necessarily become aware of which individuals are in the control conditions, however, they do not know which of the remaining participants are assigned to active cannabis versus placebo conditions (i.e., the active vs. placebo cannabis cigarettes are not labeled as such). Most importantly, outcome assessors such as the officers and driving evaluators who supply the ratings that comprise the focal dependent variables will be completely blind to experimental condition, so that there is no straightforward means by which experimenter bias could affect data collected for those variables.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Research & Development Branch

Model Details: This study is a true experiment in a naturalistic setting designed to maximize ecological validity, that is, designed so that the findings can be expected to generalize to their real-world application of detecting impaired driving. The study features a randomized between-subjects design, in which the main independent variable (Substance) has three levels: active cannabis vs. placebo vs. control (i.e., no substance).

Study Record Dates

• First Submitted: May 28, 2021
• First Posted: September 29, 2023
• Study Start: October 3, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 29, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)