CompletedEarly Phase 1

Reward and Drug Effects on Mood and Brain Response

United States141 participantsStarted 2021-03-16

Plain-language summary

The goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults.

Who can participate

Age range18 Years – 25 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * must be able to give informed consent * age 18-25 at the time of signing the consent form * fluency in English * body mass index of 19-26 (normal/overweight but not obese due to limitations of MRI) * negative urine drug screen (UDS) for all substances except THC (THC allowed) * must be medically and neurologically healthy * must not be taking psychoactive medications that would interfere with dronabinol and/or interpretation of fMRI data, including but not limited to the following classes of psychotropics: antidepressants, anxiolytics, sedative hypnotics, stimulants, antipsychotics, mood stabilizer * have used cannabis at least 10 times in their life, but report current and past lifetime cannabis use less than 7 days/week (daily) Exclusion Criteria: * any current medical condition requiring psychoactive/psychotropic medication or medication that would interact with dronabinol, interpretation of fMRI data, and/or interfere with study procedures * current or past allergic or adverse reaction or known sensitivity to cannabinoid-like substances (Dronabinol/Marijuana/Cannabis/THC, cannabinoid oil, sesame oil, gelatin, glycerin, and titanium dioxide.) * current Axis-I Diagnostic Statistical Manual-5 diagnosis (although mild and moderate Cannabis Use Disorder (CUD) and mild and moderate Alcohol Use Disorder (AUD) are allowed) * score \>3 on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) for individuals with current AUD * lifetime other lifetime …

What they're measuring

Neural reward response- Reward Positivity (RewP) event-related potential

Timeframe: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session RewP to THC session RewP.

Neural reward response- blood-oxygen-level-dependent (BOLD) response

Timeframe: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session BOLD response to THC session BOLD response.

Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale

Timeframe: First and second laboratory visit, at baseline (Time 0) and at peak drug response (90-120 minutes) after drug administration. Outcome measure is change in peak score during placebo (peak minus baseline) compared to change in peak score during THC

Trial details

NCT IDNCT04512365

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-02

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