Dronabinol + Alcohol for Driving Performance

Overseen By Karrielyn Gerlach

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Food and Drug Administration (FDA)

Must not be taking: Antidepressants, Benzodiazepines, Opiates, others

Disqualifiers: Cannabis use disorder, Alcohol intolerance, Psychiatric diagnosis, Seizures, others

Compensation: Varies

Number of Visits: 6

Duration: 6 periods with washout

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the combined effects of cannabis and alcohol on driving. It examines how different doses of dronabinol (a form of THC), both alone and with alcohol, impact driving skills and subjective experiences. The trial aims to address gaps in understanding THC's effects on driving, particularly when mixed with alcohol. Participants should be healthy adults who have occasionally used cannabis and can consume alcohol without major side effects. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to contribute to groundbreaking research on THC and driving safety.

Will I have to stop taking my current medications?

Participants must stop using any medications other than birth control 14 days before the study, unless the investigator approves them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

In a previous study, participants who took dronabinol (a form of THC, the main ingredient in cannabis) experienced some difficulty driving shortly after use. Most reported worse driving for a few hours, but it typically returned to normal after about 4-7 hours. This indicates that while dronabinol can affect driving, these effects are temporary and generally resolve within a few hours.

The FDA (Food and Drug Administration) has already approved dronabinol for treating nausea and appetite loss, indicating its safety for these uses. However, this trial tests dronabinol with alcohol, which might produce different effects, making it important to understand their interaction.

Overall, dronabinol appears well-tolerated, but caution is advised, especially when combined with alcohol. Consider personal health and comfort when deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they combine dronabinol (a synthetic form of THC) with alcohol to explore their combined effects on driving performance. Unlike standard treatments that focus on either alcohol or THC separately, this study investigates how their interaction impacts driving abilities. By examining different doses and combinations, researchers aim to better understand the risks and inform safer usage guidelines, especially as cannabis legalization expands. This research is innovative because it provides new insights into how these substances affect driving when used together, which is crucial for public safety.

What evidence suggests that this trial's treatments could be effective for driving performance?

This trial will evaluate the effects of different doses of dronabinol, a type of THC (tetrahydrocannabinol), on driving performance. Research has shown that dronabinol can affect the ability to drive safely. Studies have found that cannabis high in THC can impair driving, while cannabis high in CBD does not. Dronabinol impacts driving skills in both occasional and frequent users, with effects depending on the dose taken. For instance, after taking 20 mg of THC, driving skills might return to normal within about 5 to 7 hours. This trial will specifically assess smaller doses, like 5 mg or 10 mg, to understand how they might affect driving differently. ^{3 4 5 6 7}

Who Is on the Research Team?

Melanie Fein, MD

Principal Investigator

Spaulding Clinical Research LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in assessing the impact of oral Δ9-THC, with or without alcohol, on driving performance and perception. Participants must meet undisclosed specific criteria to join.

Inclusion Criteria

Participants must agree to refrain from using specific substances for the duration of the study

Subject must test negative for SARS-CoV-2 by a rapid antigen test at check-in

Subject signs an IRB approved written informed consent and privacy language as per national regulations before any study related procedures are performed

Exclusion Criteria

Any other condition that precludes participation in the study

History of cannabis use disorder or use of any psychoactive drug in the last month

Any reported history of alcohol intolerance

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single oral doses across six treatment conditions: 5 mg THC, 10 mg THC, 5 mg THC with alcohol, 10 mg THC with alcohol, alcohol alone, and placebo, with washout periods between treatments

6 periods with washout

6 visits (in-person)

Assessment

Driving performance and subjective effects are assessed using a driving simulator and Visual Analogue Scales (VAS) at baseline and predetermined intervals post-dose

24 hours per treatment period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dronabinol (Marinol®)

Trial Overview The study tests how different doses of oral Δ9-THC affect driving skills and subjective feelings alone and when combined with a controlled amount of alcohol (0.08% BAC).

How Is the Trial Designed?

Group I: Treatment D - 10 mg Δ9-THC + Alcohol beverage with BAC target of 0.08% Experimental Treatment 1 Intervention

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%

Group II: Treatment C - 5 mg Δ9-THC + Alcohol beverage with BAC target of 0.08% Experimental Treatment 1 Intervention

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%

Group III: Treatment B - 10 mg Δ9-THC + Placebo beverage Experimental Treatment 1 Intervention

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

Group IV: Treatment A - 5 mg Δ9-THC + Placebo beverage Experimental Treatment 1 Intervention

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

Group V: Treatment E - Placebo capsule + Alcohol beverage with BAC target of 0.08% Active Control 1 Intervention

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

Group VI: Treatment F - Placebo capsule + Placebo beverage Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Food and Drug Administration (FDA)

Lead Sponsor

Trials

184

Recruited

1,553,000+

Spaulding Clinical Research LLC

Collaborator

Trials

24

Recruited

1,300+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07176208

NCT07176208 | Clinical Study to Evaluate the Effects of ... 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.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0149763421000178

tetrahydrocannabinol (Δ 9 -THC)-induced driving and ... Most driving-related skills are predicted to recover within ∼5-hs (and almost all within ∼7-hs) of inhaling 20 mg Δ 9 -THC.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9940647/

Cannabis Effects on Driving Performance: Clinical ... Media coverage of this study conveyed the findings as CBD-dominant cannabis not causing driving impairment while THC-dominant cannabis does, ...

4. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2773562

Effect of Cannabidiol and Δ9-Tetrahydrocannabinol on ... This study did not find statistically significant differences in driving performance during experimental on-road driving tests between CBD-dominant cannabis ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/j.1360-0443.2012.03928.x

Medicinal Δ9‐tetrahydrocannabinol (dronabinol) impairs ... Dronabinol (medicinal tetrahydrocannabinol) impairs driving performance in occasional and heavy users in a dose-dependent way, but to a lesser ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/PMC8792796

Driving Performance and Cannabis Users' Perception of ... Worse driving performance is evident for several hours postsmoking in many users but appears to resolve by 4 hours 30 minutes in most ...

7. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/2788264

Driving Performance and Cannabis Users' Perception of ... Perception of driving impairment decreased at 1 hour 30 minutes, despite no objective improvement in driving; on average, performance was ...