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 range

18 Years – 25 Years

Sex

ALL

See this in plain English?

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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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