Reward and Drug Effects on Mood and Brain Response

NCT04512365 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: 2019-01891K23DA048132-01A1
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis Use; Healthy

Keywords

THC; adult

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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

Study Arms (2)

Placebo oral capsule

PLACEBO COMPARATOR

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

Drug: Placebo oral capsule

THC

EXPERIMENTAL

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

Drug: THC

Interventions

Placebo oral capsule DRUG

A capsule that contains only dextrose filler administered during the first or second laboratory visit.

Also known as: Dextrose

Placebo oral capsule

THC DRUG

A capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit.

Also known as: Marinol

THC

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Glucose; Dronabinol

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Natania A Crane, PhD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: THC or placebo will be prescribed to participants by a licensed psychiatrist, and dispensed by the University of Illinois at Chicago's Investigational Drug Service (IDS). Staff at the Clinical Research Center will give the drug or placebo to participants with the PI or a physician designate, present on-site and/or available by pager.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Half of the participants will receive placebo during the first laboratory visit and THC during the second laboratory visit. The other half of participants will receive THC during the first laboratory visit and placebo during the second laboratory visit.

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 13, 2020
• Study Start: March 16, 2021
• Primary Completion: May 2, 2025
• Study Completion: May 2, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)