Cannabis Use DisorderPhase 2NCT07225777
Sex Differences in Neurobehavioral Response to THC
A Phase 2 study testing Dronabinol in people with Cannabis Use Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial summary
This study investigates sex differences in reward processing following acute THC administration in adults with cannabis use disorder (CUD). Using multimodal neuroimaging (MRS and fMRI), the study will assess glutamate levels in the nucleus accumbens and striatal BOLD response to monetary reward anticipation. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Dronabinol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2026to 31 Aug 2026
- Phase
- Phase 2
- 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 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 21-45
- DSM-5 criteria for CUD
- Cannabis use ≥4 days/week
- THC-positive urine
- BMI 18-30
- Regular menstrual cycle (females)
- Willingness to use non-hormonal birth control (females)
Who cannot join
- Lifetime psychotic or bipolar disorder
- Recent drug use other than cannabis
- Current psychotropic medication
- Treatment-seeking for SUD
- Current psychiatric disorder (except mild alcohol, nicotine, or caffeine use disorder)
- Pregnancy/nursing
- MRI contraindications
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29403
About this study
Official title: Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder
This study investigates sex differences in reward processing following acute THC administration in adults with cannabis use disorder (CUD). Using multimodal neuroimaging (MRS and fMRI), the study will assess glutamate levels in the nucleus accumbens and striatal BOLD response to monetary reward anticipation. Participants will complete two counterbalanced dosing sessions (oral THC 40 mg vs. placebo).
- Conditions
- Cannabis Use Disorder
- Being tested
- Dronabinol, Placebo
- Keywords
- Substance Use
- 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.
DronabinolDrug
Also called Marinol
Oral dronabinol capsules (40 mg)
PlaceboDrug
Matched placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Males | Other | Not described Receives: Drug: Dronabinol; Drug: Placebo |
| Females | Other | Not described Receives: Drug: Dronabinol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nucleus accumbens glutamate
Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Measured: 2 hours post-dose
Striatal reward anticipation
Blood oxygen-level-dependent (BOLD) signaling in the striatum (caudate, putamen, nucleus accumbens) measured using functional magnetic resonance imaging (fMRI) during a monetary reward task
Measured: 3 hours post-dose
Secondary outcomes (4)
Drug Effects Questionnaire (DEQ) - Like Drug Effect
Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Measured: 0-7 hours
Drug Effects Questionnaire (DEQ) - Want More
Visual Analog Scale rating of subjective desire for more of the same drug included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Measured: 0-7 hours
Drug Effects Questionnaire (DEQ) - High
Visual Analog Scale rating of subjective "high" included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none/extreme designation.
Measured: 0-7 hours
Nucleus accumbens GABA
Concentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy
Measured: 2 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start27 Apr 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Why it stopped: Funding status change.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies 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
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Erin Martin, Ph.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07225777
- Sponsor's protocol ID
- Pro00148223
- Other IDs
- K12DA031794
- Status last verified
- Oct 2026
- First submitted
- 5 Nov 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT07225777
- Acronym / sponsor ID
- Pro00148223
- Conditions
- Cannabis Use Disorder
- Keywords
- Substance Use
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding status change.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
- Study start
- 27 Apr 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 10 Nov 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.
This study investigates sex differences in reward processing following acute THC administration in adults with cannabis use disorder (CUD). Using multimodal neuroimaging (MRS and fMRI), the study will assess glutamate levels in the nucleus accumbens and striatal BOLD response to monetary reward anticipation. Participants will complete two counterbalanced dosing sessions (oral THC 40 mg vs. placebo).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Males | Other | Drug: Dronabinol, Drug: Placebo |
| Females | Other | Drug: Dronabinol, Drug: Placebo |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 21-45
- DSM-5 criteria for CUD
- Cannabis use ≥4 days/week
- THC-positive urine
- BMI 18-30
Key exclusion criteria (7 listed)
- Lifetime psychotic or bipolar disorder
- Recent drug use other than cannabis
- Current psychotropic medication
- Treatment-seeking for SUD
- Current psychiatric disorder (except mild alcohol, nicotine, or caffeine use disorder)
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 |
|---|---|---|
| DronabinolAlso: MarinolOral dronabinol capsules (40 mg) | Drug | Females, Males |
| PlaceboMatched placebo capsules | Drug | Females, Males |
Primary outcome
Nucleus accumbens glutamate
Time frame: 2 hours post-dose
Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy
Striatal reward anticipation
Time frame: 3 hours post-dose
Blood oxygen-level-dependent (BOLD) signaling in the striatum (caudate, putamen, nucleus accumbens) measured using functional magnetic resonance imaging (fMRI) during a monetary reward task
4 secondary outcomes
Drug Effects Questionnaire (DEQ) - Like Drug Effect
Time frame: 0-7 hours
Drug Effects Questionnaire (DEQ) - Want More
Time frame: 0-7 hours
Drug Effects Questionnaire (DEQ) - High
Time frame: 0-7 hours
Nucleus accumbens GABA
Time frame: 2 hours post-dose
Results and safety
The study was stopped early (reason given: Funding status change.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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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.
Erin Martin, Ph.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dronabinol in people with Cannabis Use Disorder, run by Medical University of South Carolina 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 7 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 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. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Funding status change.). Results are not available in the source record.
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?
Nucleus accumbens glutamate (time frame: 2 hours post-dose). The study lists 2 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 6 Oct 2026.