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

NCT07176208 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SCR-017
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cannabis, Drug Effects; Driving Performance

Keywords

delta-9-tetrahydrocannabinol; Cannabis drug effects; Driving Performance; Subjective Perception; THC and alcohol

Outcome Measures

Primary Outcomes (1)

• Simulated driving performance as measured by Standard Deviation of Lateral Position (SDLP) after Δ9-THC administration alone or in combination with alcohol compared to alcohol alone.

  Simulated driving performance will be measured by the endpoint standard deviation of lateral position (SDLP) using a STISIM (model M4000-R) driving simulator after Δ9-THC administration (5 mg, 10 mg, 5 mg with alcohol, 10 mg with alcohol) compared to active control (alcohol alone).

  Up to 8 hours after study drug administration.

Secondary Outcomes (12)

• Simulated driving performance as measured by Standard Deviation of Lateral Position (SDLP) after Δ9-THC administration alone or in combination with alcohol compared to placebo.

  Up to 8 hours after study drug administration.

• Simulated driving performance as measured by Standard Deviation of Speed Position (SDSP) after Δ9-THC administration alone or in combination with alcohol compared to placebo.

  Up to 8 hours after study drug administration.

• Simulated driving performance as measured by Standard Deviation of Speed Position (SDSP) after Δ9-THC administration alone or in combination with alcohol compared to alcohol alone.

  Up to 8 hours after study drug administration.

• Maximum subjective self-rated driving impairment after Δ9-THC administration alone or in combination with alcohol compared to placebo.

  Up to 24 hours after study drug administration.

• Maximum subjective feeling state of VAS "Drug Effect" after Δ9-THC administration alone or in combination with alcohol compared to placebo.

  Up to 24 hours after study drug administration.

Study Arms (6)

Treatment A - 5 mg Δ9-THC + Placebo beverage

EXPERIMENTAL

Subjects in this arm will receive one 5 mg oral dose of THC and a placebo beverage

Drug: 5 mg Dronabinol (Marinol®) + Placebo Beverage

Treatment B - 10 mg Δ9-THC + Placebo beverage

EXPERIMENTAL

Subjects in this arm will receive one 10 mg oral dose of THC and a placebo beverage

Drug: 10 mg Dronabinol (Marinol®) + Placebo Beverage

Treatment C - 5 mg Δ9-THC + Alcohol beverage with BAC target of 0.08%

EXPERIMENTAL

Subjects in this arm will receive one 5 mg oral dose of THC and an alcohol beverage targeting a blood alcohol concentration (BAC) of 0.08%

Drug: 5 mg Dronabinol (Marinol®) + Alcohol Beverage

Treatment D - 10 mg Δ9-THC + Alcohol beverage with BAC target of 0.08%

EXPERIMENTAL

Subjects in this arm will receive one 10 mg oral dose of THC and an alcohol beverage targeting a blood alcohol concentration (BAC) of 0.08%

Drug: 10 mg Dronabinol (Marinol®) + Alcohol Beverage

Treatment E - Placebo capsule + Alcohol beverage with BAC target of 0.08%

ACTIVE COMPARATOR

Subjects in this arm will receive one placebo capsule and an alcohol beverage targeting a blood alcohol concentration (BAC) of 0.08% as a positive control

Drug: Placebo Capsule + Alcohol Beverage

Treatment F - Placebo capsule + Placebo beverage

PLACEBO COMPARATOR

Subjects in this arm will receive one placebo capsule and a placebo beverage

Drug: Placebo Capsule + Placebo Beverage

Interventions

5 mg Dronabinol (Marinol®) + Placebo Beverage DRUG

Subjects in this arm will receive one dose of 5 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.

Treatment A - 5 mg Δ9-THC + Placebo beverage

10 mg Dronabinol (Marinol®) + Placebo Beverage DRUG

Subjects in this arm will receive one dose of 10 mg THC (Dronabinol) with a placebo beverage in one of the assigned treatment days.

Treatment B - 10 mg Δ9-THC + Placebo beverage

5 mg Dronabinol (Marinol®) + Alcohol Beverage DRUG

Subjects in this arm will receive one dose of 5 mg THC (Dronabinol) with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.

Treatment C - 5 mg Δ9-THC + Alcohol beverage with BAC target of 0.08%

10 mg Dronabinol (Marinol®) + Alcohol Beverage DRUG

Subjects in this arm will receive one dose of 10 mg THC (Dronabinol) with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.

Treatment D - 10 mg Δ9-THC + Alcohol beverage with BAC target of 0.08%

Placebo Capsule + Alcohol Beverage DRUG

Subjects in this arm will receive placebo capsule with an alcoholic beverage (to achieve a target BAC of 0.08%) in one of the assigned treatment days.

Treatment E - Placebo capsule + Alcohol beverage with BAC target of 0.08%

Placebo Capsule + Placebo Beverage DRUG

Subjects in this arm will receive a placebo capsule with a placebo beverage in one of the assigned treatment days.

Treatment F - Placebo capsule + Placebo beverage

Eligibility Criteria

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

You may qualify if:

• Subject signs an IRB approved written informed consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization) before any study related procedures are performed.
• Subject is a healthy, non-smoking man or woman, 21 to 55 years of age, inclusive, who weighs at least 50 kg (110 lbs) and has a body mass index of 18.5 to 33.0 kg/m2, inclusive, at Screening and check-in (Day -1).
• Subject possesses a valid U.S. driver's license and has driven a minimum of 600 miles per year for the previous 3 years.
• During screening subjects will be assessed using a driving simulation test. Subject must not demonstrate any motion sickness as determined by the investigator and defined in the driving simulation operations manual and subject must not have erratic driving as defined in the Screening Visit Driving Practice Assessment Operational Manual.
• Subject has normal medical history findings, clinical laboratory results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening and check-ins or, if abnormal, the abnormality is not considered clinically significant (as determined and documented by the investigator or designee). Out of range tests may be repeated once for confirmation at screening and/or check-ins at investigator's discretion.
• Subject is an occasional user of cannabis, defined as having at least one cannabis exposure within the last 6 months, but no daily use pattern and no cannabis exposure within the past month.
• Subject has consumed alcohol equivalent to achieving approximately 0.10% BAC (approximately 3-4 standard drinks for females and 4-5 drinks for males over 1-2 hours) within the past year without experiencing significant adverse reactions. (Note: 1 standard drink = 12 ounces of beer \[5% alcohol by volume\], 5 ounces of wine \[12% alcohol by volume\], or 1.5 ounce of distilled spirits \[40% alcohol\]).
• Subject must report at least 1 instance of simultaneous alcohol and cannabis use over the past one year without experiencing significant adverse reactions based on investigator discretion.
• Participants must agree to refrain from using any of the following for the duration of the study: alcohol, nicotine containing products, marijuana (except for provided study drug) or marijuana-derived products, hemp or hemp-derived products, including CBD, and illicit drugs of any kind. Only THC and alcohol administered at the study site will be permitted.
• Subject must test negative for severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) by a rapid antigen test at check-in. If a subject's test comes back as invalid, the test can be repeated.
• Female subjects must be of non-childbearing potential (non-childbearing potential includes post-menopausal females defined as spontaneous amenorrhea for at least 12 months with FSH in the post-menopausal range or females who have undergone a surgical procedure that prevents pregnancy (e.g., hysterectomy, bilateral tubal ligation, occlusion, or salpingo-oophorectomy) or, if they are of childbearing potential, they must have negative serum HCG at screening and check-in and be practicing 2 effective methods of birth control (as determined by the investigator or designee; only one of the methods, but not both, may be a barrier technique) from Screening until at least 3 months after the end of the study. They must agree not to donate eggs for 30 days until after study completion.
• Male subjects must agree to practice 2 effective methods of birth control (as determined by the investigator or designee) beginning at check-in (Day -1) until at least 3 months after the last dose of study drug. Subject must also agree to inform female partner(s) about participation in the study and ensure they are using a highly effective form of contraception (e.g., hormonal birth control or copper IUD). Male subjects may not donate sperm for 90 days after the end of the study.
• Subject agrees to and is highly likely (as determined by the investigator) to comply with the protocol defined procedures and to complete the study.

You may not qualify if:

• A history of cannabis use disorder or use of any psychoactive drug in the last month.
• Any reported history of alcohol intolerance.
• Alcohol intolerance as detected by ethanol patch testing.
• Subject has a dry mouth or history of salivary gland disfunction or surgery.
• A history of any psychiatric diagnosis, including mood, anxiety, and psychotic disorders.
• Any family history of schizophrenia or other psychotic illness.
• Any history of seizures, epilepsy, or traumatic brain injury.
• History of syncope within 3 months prior to screening or any history of recurrent and/or unexplained episodes of syncope.
• A positive test result for alcohol and drugs of abuse (amphetamines, barbiturates, benzodiazepines, cocaine, alcohol, opiates, phencyclidine, propoxyphene, methadone, ) at screening and check-in (Day -1).
• Use or intend to use any medications other than birth control, including prescription, OTC, herbal or recreational products (excluding cannabis) in the 14 days prior to check-in (Day -1), unless deemed acceptable by the investigator.
• Currently participating in another clinical study of an investigational drug or has been treated with any investigational drug within 30 days or 5 half-lives (whichever is longer) of dosing for this study.
• Subject has used nicotine-containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, electronic cigarettes) within 6 weeks of Screening. Subjects must refrain from using these throughout the study.
• Subject is unable to tolerate a controlled, quiet study conduct environment, including avoidance of music, television, movies, games, and activities that may cause excitement, emotional tension, or arousal during the prespecified time points.
• Subject has known or suspected allergies or sensitivities to the study drug, delta 9-THC or sesame seeds/oil.
• Subject has a history of consuming more than 14 units of alcoholic beverages per week within 6 months before Screening, has a history of alcohol use disorder or drug/chemical/substance abuse within 2 years before Screening (Note: 1 unit = 12 ounces of beer, 5 ounces of wine, or 1.5 ounce of spirits/hard liquor).

Sponsors & Collaborators

• Spaulding Clinical Research LLC: collaborator
• Food and Drug Administration (FDA): lead

Study Sites (2)

Spaulding Clinical Research

West Bend, Wisconsin, 53095, United States

RECRUITING

Spaulding Clinical

West Bend, Wisconsin, 53095, United States

RECRUITING

Related Publications (15)

• 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.

  PMID: 36147331 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.

  PMID: 36322184 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.

  PMID: 28376280 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.

  PMID: 3690446 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.

  PMID: 25957748 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.

  PMID: 34403895 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.

  PMID: 23220273 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.

  PMID: 22553980 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.

  PMID: 37045988 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.

  PMID: 37129083 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.

  PMID: 26144593 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.

  PMID: 38074719 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.

  PMID: 33258890 BACKGROUND

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol; Ethanol

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Alcohols

Study Officials

• Melanie Fein, MD

  Spaulding Clinical Research LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Trupti Indurkar

CONTACT

3475740355; trupti.indurkar@spauldingclinical.com

Karrielyn Gerlach

CONTACT

9205172167; karrielyn.gerlach@spauldingclinical.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will be double-blind, and the blind will be maintained through a randomization schedule held by the dispensing pharmacist. The pharmacist (and designated staff member responsible for confirmation of study drug dose and measurement of blood alcohol concentration) will be unblinded to subject treatment assignment; however, the pharmacist and any unblinded staff will not perform any study procedures other than study drug preparation, and dispensing, and measuring blood alcohol concentration. An unblinded staff will have no communication of results to any blinded study personnel during the study assessments. Blinded staff will not have access to participants' BAC results until all study assessments are complete before the checkout procedure begins.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, 6-period crossover study in 48 healthy adult volunteers. This study has six 1-day treatment periods with at least 7-day washout between each period.

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 16, 2025
• Study Start: December 29, 2025
• Primary Completion: April 14, 2026
• Study Completion: April 14, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available at the time of manuscript publication.
• Access Criteria: No restrictions

Locations

US (2)