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

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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+