Reward and Drug Effects on Mood and Brain Response

University of Illinois

Status and phase: Completed; Early Phase 1

Conditions: Healthy; Cannabis Use

Treatments: Drug: THC; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04512365

2019-0189

1K23DA048132-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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
• 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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141 participants in 2 patient groups, including a placebo group

Placebo oral capsule

Placebo Comparator group

Description:

Participants will receive a placebo at their first or second laboratory visit.

Treatment:

Drug: Placebo oral capsule

THC

Experimental group

Description:

Participants will receive THC (7.5 mg) at their first or second laboratory visit.

Treatment:

Drug: THC