Reward and Drug Effects on Mood and Brain Response

NCT ID: NCT04512365

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2025-05-02

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Placebo oral capsule

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

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

THC

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

Group Type: EXPERIMENTAL

THC

Intervention Type: DRUG

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

Interventions

Placebo oral capsule

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

Intervention Type: DRUG

THC

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

Intervention Type: DRUG

Other Intervention Names

Dextrose; Marinol

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
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Natania A Crane

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Natania A Crane, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Other Identifiers

1K23DA048132-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019-0189

Identifier Type: -

Identifier Source: org_study_id