Cannabis UseEarly Phase 1NCT04512365
Reward and Drug Effects on Mood and Brain Response
A Early Phase 1 study testing THC in people with Cannabis Use and Healthy, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis Use, 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
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Mar 2021to 2 May 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- must be able to give informed consent
- age 18-25 at the time of signing the consent form
- fluency in English
- body mass index of 19-26 (normal/overweight but not obese due to limitations of MRI)
- negative urine drug screen (UDS) for all substances except THC (THC allowed)
- must be medically and neurologically healthy
- must not be taking psychoactive medications that would interfere with dronabinol and/or interpretation of fMRI data, including but not limited to the following classes of psychotropics: antidepressants, anxiolytics, sedative hypnotics, stimulants, antipsychotics, mood stabilizer
- have used cannabis at least 10 times in their life, but report current and past lifetime cannabis use less than 7 days/week (daily)
Who cannot join
- any current medical condition requiring psychoactive/psychotropic medication or medication that would interact with dronabinol, interpretation of fMRI data, and/or interfere with study procedures
- 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.)
- current Axis-I Diagnostic Statistical Manual-5 diagnosis (although mild and moderate Cannabis Use Disorder (CUD) and mild and moderate Alcohol Use Disorder (AUD) are allowed)
- score >3 on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) for individuals with current AUD
- lifetime other lifetime Substance Use Disorder (although lifetime severe CUD and lifetime severe AUD are allowed)
- currently seeking or engaged in CUD treatment or have desire to cut down or stop cannabis use.
Show all 21Show fewer
- in recovery or enrolled in treatment for any substance (including cannabis and alcohol)
- lifetime psychosis, mania, Attention-Deficit/Hyperactivity Disorder, Obsessive-Compulsive disorder, Feeding and Eating disorder, or Post-Traumatic Stress Disorder
- score >7 on the Hamilton Depression Rating Scale or score >7 on the Hamilton Anxiety Rating Scale
- less than a high school education
- lack of fluency in English
- night shift work
- currently pregnant confirmed by urine pregnancy test or planning pregnancy or lactating (women)
- unwilling/unable to sign informed consent document
- inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report
- left-handed
- presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel/retained particles)
- positive UDS for any drug except THC
- positive breathalyzer for acute alcohol intoxication
- heavy alcohol use (>4 days week) in the past month
- heavy nicotine use (>20 cigarettes per week) in the past month
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Brain-Behavior Markers of Reward and Drug Effects in Young Adults
The goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults.
- Conditions
- Cannabis Use, Healthy
- Being tested
- Placebo oral capsule, THC
- Keywords
- THC, adult
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo oral capsuleDrug
Also called Dextrose
A capsule that contains only dextrose filler administered during the first or second laboratory visit.
THCDrug
Also called Marinol
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.
Neural reward response- Reward Positivity (RewP) event-related potential
Participants will complete the Doors task during electroencephalogram (EEG) capturing the RewP, with higher values indicating greater neural response to reward
Measured: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session RewP to THC session RewP.
Neural reward response- blood-oxygen-level-dependent (BOLD) response
Participants will complete the Doors task during functional magnetic resonance imaging (fMRI) capturing BOLD response, with higher values indicating greater BOLD activation to reward
Measured: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session BOLD response to THC session BOLD response.
Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale
Participants will complete the ARCI-MBG self-report scale, with higher values reflecting more drug-induced euphoria
Measured: First and second laboratory visit, at baseline (Time 0) and at peak drug response (90-120 minutes) after drug administration. Outcome measure is change in peak score during placebo (peak minus baseline) compared to change in peak score during THC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start16 Mar 2021
- Primary completion2 May 2025
- Study completion2 May 2025
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.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- 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
- Model description
- Half of the participants will receive placebo during the first laboratory visit and THC during the second laboratory visit. The other half of participants will receive THC during the first laboratory visit and placebo during the second laboratory visit.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Natania A Crane, University of Illinois Chicago
- Investigators
- Natania A Crane, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512365
- Sponsor's protocol ID
- 2019-0189
- Other IDs
- 1K23DA048132-01A1
- Status last verified
- May 2025
- First submitted
- 6 Aug 2020
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Behavior Markers of Reward and Drug Effects in Young Adults
- ClinicalTrials.gov ID
- NCT04512365
- Acronym / sponsor ID
- 2019-0189
- Conditions
- Cannabis Use, Healthy
- Keywords
- THC, adult
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 2 May 2025 (actual)
- Study completion
- 2 May 2025 (actual)
- First posted
- 13 Aug 2020 (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 goal of the study is to better understand the neural mechanisms underlying the rewarding, reinforcing properties of delta-9-tetrahydrocannabinol (THC), the main psychoactive ingredient in cannabis, among healthy young adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Half of the participants will receive placebo during the first laboratory visit and THC during the second laboratory visit. The other half of participants will receive THC during the first laboratory visit and placebo during the second laboratory visit.
| 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 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- must be able to give informed consent
- age 18-25 at the time of signing the consent form
- fluency in English
- body mass index of 19-26 (normal/overweight but not obese due to limitations of MRI)
- negative urine drug screen (UDS) for all substances except THC (THC allowed)
Key exclusion criteria (21 listed)
- any current medical condition requiring psychoactive/psychotropic medication or medication that would interact with dronabinol, interpretation of fMRI data, and/or interfere with study procedures
- 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.)
- current Axis-I Diagnostic Statistical Manual-5 diagnosis (although mild and moderate Cannabis Use Disorder (CUD) and mild and moderate Alcohol Use Disorder (AUD) are allowed)
- score >3 on the Prediction of Alcohol Withdrawal Severity Scale (PAWSS) for individuals with current AUD
- lifetime other lifetime Substance Use Disorder (although lifetime severe CUD and lifetime severe AUD are allowed)
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 capsuleAlso: DextroseA capsule that contains only dextrose filler administered during the first or second laboratory visit. | Drug | Placebo oral capsule |
| THCAlso: MarinolA 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
Neural reward response- Reward Positivity (RewP) event-related potential
Time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session RewP to THC session RewP.
Participants will complete the Doors task during electroencephalogram (EEG) capturing the RewP, with higher values indicating greater neural response to reward
Neural reward response- blood-oxygen-level-dependent (BOLD) response
Time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session BOLD response to THC session BOLD response.
Participants will complete the Doors task during functional magnetic resonance imaging (fMRI) capturing BOLD response, with higher values indicating greater BOLD activation to reward
Subjective drug response- Addiction Research Center Inventory (ARCI)- Morphine Benzedrine Group (MBG) subscale
Time frame: First and second laboratory visit, at baseline (Time 0) and at peak drug response (90-120 minutes) after drug administration. Outcome measure is change in peak score during placebo (peak minus baseline) compared to change in peak score during THC
Participants will complete the ARCI-MBG self-report scale, with higher values reflecting more drug-induced euphoria
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Natania A Crane, PhD principal investigator
University of Illinois Chicago
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 Healthy, run by University of Illinois 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 8 inclusion and 21 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: finished, as of the sponsor's last update on 21 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural reward response- Reward Positivity (RewP) event-related potential (time frame: First and second laboratory visits, around 90 minutes to 2 hours after drug administration. Outcome measure is change from placebo session RewP to THC session RewP.). The study lists 3 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 21 May 2025.