Research Investigating Drug Effects-2 (RiDE-2)

Early Phase 1

Not yet recruiting

• Conditions: Cannabis Use; Healthy; Substance Use Disorder (SUD)
• Interventions: Drug: Placebo Oral Capsule; Drug: THC

• Registration Number: NCT06758596
• Lead Sponsor: University of Illinois at Chicago

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2024-12-26
• Last Update Submitted: 2024-12-26
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Study Start: 2025-07-15
• Primary Completion: 2030-02
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo oral capsule	Placebo Oral Capsule	Participants will receive a placebo at their first or second laboratory visit.
THC	THC	Participants will receive THC (7.5 mg) at their first or second laboratory visit.

Primary Outcome Measures

Name	Time	Method
Recent Substance Use	Baseline screening, baseline drug administration, and every 6 months over two years of follow-up	Participants will complete the 6-month Timeline Follow-Back (TLFB) and Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU) to assess recent substance use. This measure will capture the frequency of substance use during the past 6 months, with greater values indicating more frequent substance use.
CUD/SUD Symptoms	Baseline screening and yearly over the two-year follow-up.	Participants will complete the SCID CUD diagnosis and symptom assessment at baseline screening and yearly follow-ups to evaluate the presence and severity of cannabis use disorder (CUD) and other substance use disorder (SUD) symptoms.
Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter)	First and second laboratory visits, around 90 minutes to 2 hours after drug administration.	Participants will complete the Bandit task during fMRI scanning. A behavioral measure of learning rate (alpha parameter) will be derived from computational models based on the Rescorla-Wagner (RW) model, with higher learning rates indicating greater learning and adaptation to reward contingencies.
Neural Reward Anticipation - fMRI response to reward anticipation (MID)	First and second laboratory visits, around 90 minutes to 2 hours after drug administration.	Participants will complete the Monetary Incentive Delay (MID) task during fMRI scanning to assess neural activation related to reward anticipation. Greater activation in reward-related brain regions (e.g., striatum, prefrontal cortex) indicates greater neural sensitivity to anticipated rewards and the impact of THC on reward processing.
Computationally-Derived Behavioral Reward Sensitivity - Reward sensitivity (inverse temperature parameter)	First and second laboratory visits, around 90 minutes to 2 hours after drug administration.	Participants will complete the Bandit task during fMRI scanning, and a behavioral measure of reward sensitivity will be derived from the Rescorla-Wagner (RW) model. Greater values indicate higher sensitivity to rewards and a stronger preference for rewarding outcomes.
Neural Encoding of Reward Prediction Errors - fMRI response to reward prediction errors (Bandit Task)	First and second laboratory visits, around 90 minutes to 2 hours after drug administration.	Participants will complete the Bandit task during fMRI scanning. fMRI analysis will focus on trial-wise neural encoding of prediction errors, with greater activation indicating more salient reward learning signals in response to prediction errors, reflecting how the brain processes unexpected outcomes during reward learning.

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States