Reward and Drug Effects on Mood and Brain Response

Healthy Clinical Trial

Official title:

Brain-Behavior Markers of Reward and Drug Effects in Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04512365
• Other study ID #: 2019-0189
• Secondary ID: 1K23DA048132-01A
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 16, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: University of Illinois at Chicago
• Contact: Natania A Crane, PhD
• Phone: 312-413-4453
• Email: ncrane3[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Cannabis Use
• Healthy

Intervention

Drug:
• Placebo oral capsule
A capsule that contains only dextrose filler administered during the first or second laboratory visit.
• THC
A capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit.

Locations

Country	Name	City	State
United States	University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neural reward response- Reward Positivity (RewP) event-related potential	Participants will complete the Doors task during electroencephalogram (EEG) capturing the RewP, with higher values indicating greater neural response to reward	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.
Primary	Neural reward response- blood-oxygen-level-dependent (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	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.
Primary	Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale	Participants will complete the ARCI-MBG self-report scale, with higher values reflecting more drug-induced euphoria	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