Clinical trial NCT06758596: Research Investigating Drug Effects-2 (RiDE-2)
Official title: Research Investigating Drug Effects-2 (RiDE-2)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Cannabis Use
Substance Use Disorder (SUD)
Healthy
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Recent Substance Use
timeFrame: Baseline screening, baseline drug administration, and every 6 months over two years of follow-up
measure: CUD/SUD Symptoms
timeFrame: Baseline screening and yearly over the two-year follow-up.
measure: Neural Reward Anticipation - fMRI response to reward anticipation (MID)
timeFrame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
measure: Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter)
timeFrame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
measure: Computationally-Derived Behavioral Reward Sensitivity - Reward sensitivity (inverse temperature parameter)
timeFrame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
measure: Neural Encoding of Reward Prediction Errors - fMRI response to reward prediction errors (Bandit Task)
timeFrame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
References: