Research Investigating Drug Effects-2 (RiDE-2)

University of Illinois

Status and phase: Begins enrollment in 5 months; Early Phase 1

Conditions: Healthy; Cannabis Use; Substance Use Disorder (SUD)

Treatments: Drug: Placebo Oral Capsule; Drug: THC

Study type: Interventional

Funder types: Other

Identifiers

NCT06758596

STUDY2024-0596

Details and patient eligibility

About

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.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 21 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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144 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