Research Investigating Drug Effects-2 (RiDE-2)

NCT ID: NCT06758596

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 144 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-07-15
• Study Completion Date: 2031-06-30

Brief Summary

The purpose of this study is to better understand how people's mood, behavior, and brains respond to different recreational drugs. We are also trying to understand why some people may feel differently or their brain may respond differently than other people after taking the same recreational drug.

Conditions

Cannabis Use; Substance Use Disorder (SUD); Healthy

Study Design

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

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

Eligibility Criteria

Inclusion Criteria

• age 18-21 at eligibility visit
• body mass index of 18.5-30
• report using cannabis ≥10 times in their life and ≥1 time in the past 3 months, but <7 days a week (daily)
• medically and neurologically healthy
• score of ≥0.25 on the Personality Inventory for DSM-5 (PID-5) Anhedonia subscale

Exclusion Criteria

• positive urine drug screen (UDS; except for THC) and/or positive saliva THC test
• contraindication for fMRI BOLD study (e.g., metal implants)
• severe mental illness (e.g., psychosis, mania, lifetime moderate-to-severe SUD (including moderate-to-severe CUD))
• heavy nicotine use in the past month (>20 cigarettes per week or electronic nicotine delivery system (ENDS) use equivalent
• night shift work
• females who are currently pregnant confirmed by urine pregnancy test, are planning pregnancy, or are lactating
• unwilling/unable to sign informed consent document
• 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)
• physical or neurological diagnoses (e.g., cancer, diabetes, seizure disorder, Parkinson's, Multiple Sclerosis, loss of consciousness >10 min., etc.) that in the opinion of the Study Physician and Investigators could increase safety risks or influence the findings
• currently taking any medication that could interact with a single dose of Δ9-THC

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Illinois at Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Illinois at Chicago

Chicago, Illinois, United States

Countries

United States

Central Contacts

Natania Crane, PhD

Role: CONTACT

ncrane3@uic.edu

(312) 413-4453

Facility Contacts

Natania Crane, PhD

Role: primary

ncrane3@uic.edu

312-413-4453

Other Identifiers

STUDY2024-0596

Identifier Type: -

Identifier Source: org_study_id