NCT05273658

Brief Summary

The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and tetrahydrocannabinol (THC), 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo. Cannabis inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid/saliva, breath) over the subsequent 4 hours after ingestion. The purpose of this study is to determine (1) the impact of Δ9-THC on driving performance with and without concurrent alcohol ingestion (2) the duration of driving impairment in terms of hours from initial use, (3) the relationship between performance on the DRE measures and cannabis/alcohol ingestion, and 4) if saliva or expired air can serve as a useful adjunct to the field for blood sampling.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

10 months

First QC Date

February 28, 2022

Last Update Submit

September 2, 2023

Conditions

Driving ImpairedAlcohol IntoxicationDriving Under the InfluenceCannabis Intoxication

Keywords

CannabisAlcoholDriving

Outcome Measures

Primary Outcomes (1)

  • Composite Drive Score

    The Composite Drive Score (CDS) is a z-score comprised of key variables from the simulator tasks (SDLP, speed deviation, and task accuracy during the modified Surrogate Reference Task (mSuRT); coherence from the car following task). This outcome reflects the change in CDS from the pre-smoking assessment, at each timepoint. The z-score indicates the number of standard deviations away from the mean from the baseline performance for the entire group. A Z-score of 0 is equal to the mean of a reference population (in this case the pre-smoking performance for the entire group). Higher z-scores at each timepoint indicate worse performance (variables that went in the opposite direction were reflected in order to have all variables have the same direction). When examining the change in Composite Drive Score (this outcome variable), a higher score indicates a decline in performance (e.g., Time 2 minus Time1).

    Participants are assessed pre-smoking/drinking, and then approximately 30 minutes, 1 hour 30 minutes, and 3 hours 30 minutes post-smoking

Secondary Outcomes (4)

  • DRE Impairment

    Approximately 1.5 hours and 2.5 hours after alcohol/cannabis administration

  • Whole blood THC concentration

    Approximately 30 minutes after alcohol/cannabis administration

  • Oral Fluid THC concentration

    Approximately 30 minutes after alcohol/cannabis administration

  • Breath THC concentration

    Approximately 30 minutes after alcohol/cannabis administration

Study Arms (5)

Placebo

PLACEBO COMPARATOR

Placebo cannabis and placebo alcohol

Drug: CannabisDrug: Alcohol

Cannabis, No alcohol

EXPERIMENTAL

18.16% THC, placebo alcohol

Drug: CannabisDrug: Alcohol

Cannabis, Low dose alcohol

EXPERIMENTAL

18.16% THC, .07 breath alcohol concentration

Drug: CannabisDrug: Alcohol

Placebo cannabis, High dose alcohol

EXPERIMENTAL

\<.1% THC, .10 Breath alcohol concentration

Drug: CannabisDrug: Alcohol

Placebo cannabis, Low dose alcohol

EXPERIMENTAL

\<.1% THC, .07 breath alcohol concentration

Drug: CannabisDrug: Alcohol

Interventions

CannabisDRUG

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

Also known as: Marijuana
Cannabis, Low dose alcoholCannabis, No alcoholPlaceboPlacebo cannabis, High dose alcoholPlacebo cannabis, Low dose alcohol
AlcoholDRUG

Participants will ingest alcohol to achieve the target breath alcohol level

Cannabis, Low dose alcoholCannabis, No alcoholPlaceboPlacebo cannabis, High dose alcoholPlacebo cannabis, Low dose alcohol

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 21 to 55
  • Must be a licensed driver and driven a minimum of 1,000 miles in the past year
  • Experience with cannabis and alcohol

You may not qualify if:

  • At the discretion of the examining physician, individuals with significant cardiovascular, hepatic or renal disease, uncontrolled hypertension, and chronic pulmonary disease (eg, asthma, COPD) will be excluded.
  • Unwillingness to abstain from cannabis for 2 days prior to screening and experimental visits
  • Positive pregnancy test
  • A positive result on toxicity screening for cocaine, amphetamines, opiates, and phencyclidine (PCP) will exclude individuals from participation.
  • Unwilling to refrain from driving or operating heavy machinery after consuming study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • Movig KL, Mathijssen MP, Nagel PH, van Egmond T, de Gier JJ, Leufkens HG, Egberts AC. Psychoactive substance use and the risk of motor vehicle accidents. Accid Anal Prev. 2004 Jul;36(4):631-6. doi: 10.1016/S0001-4575(03)00084-8.

    PMID: 15094417RESULT

  • Stuster J. Validation of the standardized field sobriety test battery at 0.08% blood alcohol concentration. Hum Factors. 2006 Fall;48(3):608-14. doi: 10.1518/001872006778606895.

    PMID: 17063973RESULT

  • Grotenhermen F, Leson G, Berghaus G, Drummer OH, Kruger HP, Longo M, Moskowitz H, Perrine B, Ramaekers JG, Smiley A, Tunbridge R. Developing limits for driving under cannabis. Addiction. 2007 Dec;102(12):1910-7. doi: 10.1111/j.1360-0443.2007.02009.x. Epub 2007 Oct 4.

    PMID: 17916224RESULT

  • Hartman RL, Brown TL, Milavetz G, Spurgin A, Gorelick DA, Gaffney G, Huestis MA. Controlled vaporized cannabis, with and without alcohol: subjective effects and oral fluid-blood cannabinoid relationships. Drug Test Anal. 2016 Jul;8(7):690-701. doi: 10.1002/dta.1839. Epub 2015 Aug 10.

    PMID: 26257143RESULT

  • Ramaekers JG, Theunissen EL, de Brouwer M, Toennes SW, Moeller MR, Kauert G. Tolerance and cross-tolerance to neurocognitive effects of THC and alcohol in heavy cannabis users. Psychopharmacology (Berl). 2011 Mar;214(2):391-401. doi: 10.1007/s00213-010-2042-1. Epub 2010 Oct 30.

    PMID: 21049267RESULT

  • Hartman RL, Brown TL, Milavetz G, Spurgin A, Pierce RS, Gorelick DA, Gaffney G, Huestis MA. Cannabis effects on driving lateral control with and without alcohol. Drug Alcohol Depend. 2015 Sep 1;154:25-37. doi: 10.1016/j.drugalcdep.2015.06.015. Epub 2015 Jun 23.

    PMID: 26144593RESULT

  • Hoffman MA, Hubbard JA, Sobolesky PM, Smith BE, Suhandynata RT, Sanford S, Sones EG, Ellis S, Umlauf A, Huestis MA, Grelotti DJ, Grant I, Marcotte TD, Fitzgerald RL. Blood and Oral Fluid Cannabinoid Profiles of Frequent and Occasional Cannabis Smokers. J Anal Toxicol. 2021 Sep 17;45(8):851-862. doi: 10.1093/jat/bkab078.

    PMID: 34173005RESULT

  • Hubbard JA, Smith BE, Sobolesky PM, Kim S, Hoffman MA, Stone J, Huestis MA, Grelotti DJ, Grant I, Marcotte TD, Fitzgerald RL. Validation of a liquid chromatography tandem mass spectrometry (LC-MS/MS) method to detect cannabinoids in whole blood and breath. Clin Chem Lab Med. 2020 Apr 28;58(5):673-681. doi: 10.1515/cclm-2019-0600.

    PMID: 31527291RESULT

MeSH Terms

Conditions

Alcoholic IntoxicationDriving Under the InfluenceMarijuana Abuse

Interventions

nabiximolsEthanol

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCriminal BehaviorBehaviorDangerous Behavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Cannabis will be dispensed from the Research Pharmacy. Alcohol will be dispensed by a research staff member who is not involved in any assessments. All assessors, investigators, and participants are blinded to the THC and alcohol content.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants will be randomized to smoke a cannabis cigarette containing placebo (.02%) or 18.1% THC, and consume alcohol to achieve a breath alcohol level of .07, .10, or 0.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 10, 2022

Study Start

August 1, 2022

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09