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Not yet recruiting NCT06758596

Research Investigating Drug Effects-2 (RiDE-2)

Early Phase I Interventional Cannabis Use Substance Use Disorder (SUD) Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Placebo Oral Capsule, THC.
Who it may be relevant to
Registry conditions: Cannabis Use, Substance Use Disorder (SUD), Healthy. Basic parameters: 18 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug Placebo Oral Capsule
    A capsule that contains only dextrose filler administered during the first or second laboratory visit.
  • Drug THC
    A capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit.

Primary outcome measures

  • Recent Substance Use [Time frame: Baseline screening, baseline drug administration, and every 6 months over two years of follow-up]
  • CUD/SUD Symptoms [Time frame: Baseline screening and yearly over the two-year follow-up.]
  • Neural Reward Anticipation - fMRI response to reward anticipation (MID) [Time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.]
  • Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter) [Time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.]
  • Computationally-Derived Behavioral Reward Sensitivity - Reward sensitivity (inverse temperature parameter) [Time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.]
  • Neural Encoding of Reward Prediction Errors - fMRI response to reward prediction errors (Bandit Task) [Time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Basic science

Study locations

United States · 1 center
  • University of Illinois at Chicago — Chicago

Identifiers

NCT: NCT06758596 · STUDY2024-0596

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗