Cannabis UseEarly Phase 1RiDE-2NCT06758596
Research Investigating Drug Effects-2 (RiDE-2)
A Early Phase 1 study testing THC in people with Cannabis Use and Substance Use Disorder (SUD), run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, Substance Use Disorder (SUD), Healthy
- What is being tested?
- THC
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2027to Jun 2031
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 21 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
Natania Crane, PhD, (312) 413-4453, ncrane3@uic.edu
About this study
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
- Being tested
- Placebo Oral Capsule, THC
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Oral CapsuleDrug
A capsule that contains only dextrose filler administered during the first or second laboratory visit.
THCDrug
A capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit.
| Study group | Role | What they receive |
|---|---|---|
| Placebo oral capsule | Placebo comparator | Participants will receive a placebo at their first or second laboratory visit. Receives: Drug: Placebo Oral Capsule |
| THC | Experimental | Participants will receive THC (7.5 mg) at their first or second laboratory visit. Receives: Drug: THC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recent Substance Use
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.
Measured: Baseline screening, baseline drug administration, and every 6 months over two years of follow-up
CUD/SUD Symptoms
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.
Measured: Baseline screening and yearly over the two-year follow-up.
Neural Reward Anticipation - fMRI response to reward anticipation (MID)
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.
Measured: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Computationally-Derived Behavioral Reward Learning Rate - Learning rate (alpha parameter)
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.
Measured: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Computationally-Derived Behavioral Reward Sensitivity - Reward sensitivity (inverse temperature parameter)
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.
Measured: 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)
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.
Measured: First and second laboratory visits, around 90 minutes to 2 hours after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2025
- Study start4 Jan 2027 (estimated)
- Primary completionMar 2031 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758596
- Sponsor's protocol ID
- STUDY2024-0596
- Acronym
- RiDE-2
- Status last verified
- Oct 2026
- First submitted
- 26 Dec 2024
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Demographic, clinical, behavioral, and fMRI data will be collected from 144 adults. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each participant.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Investigating Drug Effects-2 (RiDE-2)
- ClinicalTrials.gov ID
- NCT06758596
- Acronym / sponsor ID
- RiDE-2 / STUDY2024-0596
- Conditions
- Cannabis Use, Substance Use Disorder (SUD), Healthy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 4 Jan 2027 (estimated)
- Primary completion
- Mar 2031 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 6 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo oral capsule | Placebo comparator | Drug: Placebo Oral CapsuleParticipants will receive a placebo at their first or second laboratory visit. |
| THC | Experimental | Drug: THCParticipants will receive THC (7.5 mg) at their first or second laboratory visit. |
Who may qualify
- Ages
- 18 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo Oral CapsuleA capsule that contains only dextrose filler administered during the first or second laboratory visit. | Drug | Placebo oral capsule |
| THCA capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit. | Drug | THC |
Primary outcome
Recent Substance Use
Time frame: 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
Time frame: 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.
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.
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 Learning Rate - Learning rate (alpha parameter)
Time frame: 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.
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.
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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: Yes. Demographic, clinical, behavioral, and fMRI data will be collected from 144 adults. All data will be de-identified prior to receipt by the repository, but the information needed to generate a global unique identifier (GUID) for the NIMH Data Archive (NDA) will be collected for each participant.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing THC in people with Cannabis Use and Substance Use Disorder (SUD), run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natania Crane, PhD ((312) 413-4453, ncrane3@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recent Substance Use (time frame: Baseline screening, baseline drug administration, and every 6 months over two years of follow-up). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.