Status:
COMPLETED
Reward and Drug Effects on Mood and Brain Response
Lead Sponsor:
University of Illinois at Chicago
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis Use
Healthy
Eligibility:
All Genders
18-25 years
Phase:
EARLY_PHASE1
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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 Substance Use Disorder (although lifetime severe CUD and lifetime severe AUD are allowed)
- currently seeking or engaged in CUD treatment or have desire to cut down or stop cannabis use.
- in recovery or enrolled in treatment for any substance (including cannabis and alcohol)
- lifetime psychosis, mania, Attention-Deficit/Hyperactivity Disorder, Obsessive-Compulsive disorder, Feeding and Eating disorder, or Post-Traumatic Stress Disorder
- score \>7 on the Hamilton Depression Rating Scale or score \>7 on the Hamilton Anxiety Rating Scale
- less than a high school education
- lack of fluency in English
- night shift work
- currently pregnant confirmed by urine pregnancy test or planning pregnancy or lactating (women)
- unwilling/unable to sign informed consent document
- inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report
- left-handed
- presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- positive UDS for any drug except THC
- positive breathalyzer for acute alcohol intoxication
- heavy alcohol use (\>4 days week) in the past month
- heavy nicotine use (\>20 cigarettes per week) in the past month
Key Trial Info
Start Date :
March 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 2 2025
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT04512365
Start Date
March 16 2021
End Date
May 2 2025
Last Update
May 21 2025
Active Locations (1)
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1
University of Illinois at Chicago
Chicago, Illinois, United States, 60612