Clinical Study to Evaluate the Effects of Oral Delta-9-tetrahydrocannabinol (Δ9-THC) With and Without Alcohol on Perception and Driving Performance in Healthy Adults

Summary

With the increasing prevalence and use of cannabis products by the public, there exists a need to better understand the safety impact of cannabis use, particularly when it comes to subjective perceptions of drug effect and driving impairment. This study aims to evaluate the dose-dependent effects of oral Δ9-THC alone and in combination with alcohol (0.08% BAC \[Blood Alcohol Concentration\]) on driving performance and subjective feeling in healthy adults. The results of this study will address current knowledge gaps on the effects of oral Δ9-THC on driving impairment across a clinically relevant dose range.

Timeline

Start

2025-12-29

Primary completion

2026-04-14

Completion

2026-04-14

Publications

• Background Cleveland Clinic. Blood Alcohol Content (BAC). https://my.clevelandclinic.org/health/diagnostics/22689-blood-alcohol-content-bac
• Background Dronabinol (Marinol®) capsule label obtained from https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/018651s033lbl.pdf
• Background Zamarripa CA, Novak MD, Weerts EM, Vandrey R, Spindle TR. The effects of oral and vaporized cannabis alone, and in combination with alcohol, on driving performance using the STISIM driving simulator: A two-part, double-blind, double-dummy, placebo-controlled, randomized crossover clinical laboratory protocol. Front Pharmacol. 2022 Sep 6;13:964749. doi: 10.3389/fphar.2022.964749. eCollection 2022.
• Background Garrisson H, Scholey A, Verster JC, Shiferaw B, Benson S. Effects of alcohol intoxication on driving performance, confidence in driving ability, and psychomotor function: a randomized, double-blind, placebo-controlled study. Psychopharmacology (Berl). 2022 Dec;239(12):3893-3902. doi: 10.1007/s00213-022-06260-z. Epub 2022 Nov 2.
• Background Weerts EM, Wand GS, Maher B, Xu X, Stephens MA, Yang X, McCaul ME. Independent and Interactive Effects of OPRM1 and DAT1 Polymorphisms on Alcohol Consumption and Subjective Responses in Social Drinkers. Alcohol Clin Exp Res. 2017 Jun;41(6):1093-1104. doi: 10.1111/acer.13384. Epub 2017 Apr 26.
• Background Fisher HR, Simpson RI, Kapur BM. Calculation of blood alcohol concentration (BAC) by sex, weight, number of drinks and time. Can J Public Health. 1987 Sep-Oct;78(5):300-4. No abstract available.
• Background Veldstra JL, Bosker WM, de Waard D, Ramaekers JG, Brookhuis KA. Comparing treatment effects of oral THC on simulated and on-the-road driving performance: testing the validity of driving simulator drug research. Psychopharmacology (Berl). 2015 Aug;232(16):2911-9. doi: 10.1007/s00213-015-3927-9. Epub 2015 May 10.
• Background Brooks-Russell A, Brown T, Friedman K, Wrobel J, Schwarz J, Dooley G, Ryall KA, Steinhart B, Amioka E, Milavetz G, Sam Wang G, Kosnett MJ. Simulated driving performance among daily and occasional cannabis users. Accid Anal Prev. 2021 Sep;160:106326. doi: 10.1016/j.aap.2021.106326. Epub 2021 Aug 14.
• Background Hartman RL, Huestis MA. Cannabis effects on driving skills. Clin Chem. 2013 Mar;59(3):478-92. doi: 10.1373/clinchem.2012.194381. Epub 2012 Dec 7.
• Background Bosker WM, Kuypers KP, Theunissen EL, Surinx A, Blankespoor RJ, Skopp G, Jeffery WK, Walls HC, van Leeuwen CJ, Ramaekers JG. Medicinal Delta(9) -tetrahydrocannabinol (dronabinol) impairs on-the-road driving performance of occasional and heavy cannabis users but is not detected in Standard Field Sobriety Tests. Addiction. 2012 Oct;107(10):1837-44. doi: 10.1111/j.1360-0443.2012.03928.x. Epub 2012 Jul 12.
• Background Schnakenberg Martin AM, Flynn LT, Sefik E, Luddy C, Cortes-Briones J, Skosnik PD, Pittman B, Ranganathan M, D'Souza DC. Preliminary study of the interactive effects of THC and ethanol on self-reported ability and simulated driving, subjective effects, and cardiovascular responses. Psychopharmacology (Berl). 2023 Jun;240(6):1235-1246. doi: 10.1007/s00213-023-06356-0. Epub 2023 Apr 12.
• Background Manning B, Hayley AC, Catchlove S, Shiferaw B, Stough C, Downey LA. Effect of CannEpil(R) on simulated driving performance and co-monitoring of ocular activity: A randomised controlled trial. J Psychopharmacol. 2023 May;37(5):472-483. doi: 10.1177/02698811231170360. Epub 2023 May 2.
• Background 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.
• Background Hartley S, Simon N, Cardozo B, Larabi IA, Alvarez JC. Can inhaled cannabis users accurately evaluate impaired driving ability? A randomized controlled trial. Front Public Health. 2023 Nov 22;11:1234765. doi: 10.3389/fpubh.2023.1234765. eCollection 2023.
• Background Arkell TR, Vinckenbosch F, Kevin RC, Theunissen EL, McGregor IS, Ramaekers JG. Effect of Cannabidiol and Delta9-Tetrahydrocannabinol on Driving Performance: A Randomized Clinical Trial. JAMA. 2020 Dec 1;324(21):2177-2186. doi: 10.1001/jama.2020.21218.

Drugs

Indications