Alcohol Intoxication Clinical Trial
Official title:
Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests
Verified date | September 2023 |
Source | University of California, San Diego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | June 2023 |
Est. primary completion date | June 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 55 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of California, San Diego |
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 — View Citation
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: 10.100 — View Citation
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 J — View Citation
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 — View Citation
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 — View Citation
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. — View Citation
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/s00213-010-20 — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | DRE Impairment | DRE officers' determination regarding participant impairment | Approximately 1.5 hours and 2.5 hours after alcohol/cannabis administration | |
Secondary | Whole blood THC concentration | Whole blood THC concentrations determine via LC-MS-MS | Approximately 30 minutes after alcohol/cannabis administration | |
Secondary | Oral Fluid THC concentration | Oral fluid THC concentrations determine via LC-MS-MS | Approximately 30 minutes after alcohol/cannabis administration | |
Secondary | Breath THC concentration | Breath THC concentrations determine via LC-MS-MS | Approximately 30 minutes after alcohol/cannabis administration |
Status | Clinical Trial | Phase | |
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