Brain-Behavior Markers of Reward and Drug Effects in Young Adults
Overview
- Phase
- Early Phase 1
- Intervention
- Placebo oral capsule
- Conditions
- Cannabis Use
- Sponsor
- University of Illinois at Chicago
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- Neural reward response- Reward Positivity (RewP) event-related potential
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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, among healthy young adults.
Investigators
Natania A Crane
Assistant Professor
University of Illinois at Chicago
Eligibility Criteria
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 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
Arms & Interventions
Placebo oral capsule
Participants will receive a placebo at their first or second laboratory visit.
Intervention: Placebo oral capsule
THC
Participants will receive THC (7.5 mg) at their first or second laboratory visit.
Intervention: THC
Outcomes
Primary Outcomes
Neural reward response- Reward Positivity (RewP) event-related potential
Time Frame: 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.
Participants will complete the Doors task during electroencephalogram (EEG) capturing the RewP, with higher values indicating greater neural response to reward
Neural reward response- blood-oxygen-level-dependent (BOLD) response
Time Frame: 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.
Participants will complete the Doors task during functional magnetic resonance imaging (fMRI) capturing BOLD response, with higher values indicating greater BOLD activation to reward
Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale
Time Frame: 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
Participants will complete the ARCI-MBG self-report scale, with higher values reflecting more drug-induced euphoria