Cannabis Use DisorderPhase 2S-CUDNCT07879612
Semaglutide for the Treatment of Cannabis Use Disorder
A Phase 2 study testing semaglutide in people with Cannabis Use Disorder and Cue-reactivity, run by Massachusetts General Hospital.
Trial summary
The goal of this pilot study is to learn about the effects of semaglutide on brain reactivity to cannabis-related cues in adults with cannabis use disorder. The main questions it aims to answer are: 1. Does semaglutide effect reactivity to cannabis-related cues? 2. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cannabis Use Disorder, Cue-reactivity
- What is being tested?
- semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 10 Jan 2027to 30 Mar 2029
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years, inclusive;
- Use cannabis daily or near daily and have been using cannabis consistently for at least the past year, by self-report;
- Diagnosed with moderate to severe DSM-5 cannabis use disorder
- Access to a mobile device to complete daily surveys
- Desire to quit or reduce cannabis consumption
- Be able to read, speak, and understand the English language. English can be a second language provided that the subject understands all the questions used in the assessment measures.
Who cannot join
- Active psychosis, active suicidality (current suicidal ideation with specific plan or intent) or homicidality, suicide attempt or psychiatric hospitalization in the past year, or any psychiatric condition that may impair ability to provide informed consent.
- Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, or binge eating;
- Any current substance use disorder other than cannabis or mild alcohol use disorder;
- BMI <21 kg/m2;
- MRI contraindications (including presence of metallic foreign bodies such as cardiac pacemakers, perfusion pumps, aneurysm clips, metallic tattoos anywhere on the body, tattoos near the eye);
- Current or lifetime diagnosis of Type 1 or Type 2 diabetes;
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- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2;
- Use of any GLP-1 agonist medications in the prior 3 months;
- Anticipating use of any other GLP-1 agonist medications during the trial;
- Current hypoglycemia as indicated by a blood sugar level of <71 mg/dL measured at baseline visit;
- Untreated cholelithiasis or gallbladder disease;
- History of acute myocardial infarction, cerebrovascular accident (stroke), unstable angina, or congestive heart failure in the last year;
- Systolic blood pressure persistently above 160mmHg or diastolic blood pressure persistently above 100mmHg during screening;
- History of inflammatory bowel disease, bariatric surgery, pancreatitis, diabetic gastroparesis, or non-arteritic anterior ischemic optic neuropathy;
- Liver function test greater than 3 times upper normal limit at baseline;
- Renal impairment as indicated by eGFR of <30;
- History of hypersensitivity or allergy to semaglutide;
- Pregnant or breastfeeding;
- Currently taking GLP-1 agonists or other weight loss drugs;
- Anticipated to participate in a concurrent drug trial;
- Anticipating to undergo elective surgeries or procedure requiring general anesthesia during duration of the study;
- Any other reason or clinical condition that the investigators judge may interfere with study participation and/or be unsafe for a participant.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this pilot study is to learn about the effects of semaglutide on brain reactivity to cannabis-related cues in adults with cannabis use disorder. The main questions it aims to answer are:
- Does semaglutide effect reactivity to cannabis-related cues?
- Does semaglutide safely reduce the frequency of cannabis use?
Participants will complete five in-person study visits over 9 weeks, which will include interviews, questionnaires, and collection of biological samples for laboratory testing. fMRI scans will be completed at two visits. All participants will receive weekly injections of 0.25-0.5 mg semaglutide across 8 weeks.
- Conditions
- Cannabis Use Disorder, Cue-reactivity
- Being tested
- semaglutide
- Keywords
- Semaglutide, Cannabis use disorder, Cue-reactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
All participants will receive open-label semaglutide for 8 weeks. Semaglutide will be self-administered as a once-weekly subcutaneous injection according to standard clinical titration procedures to maximize tolerability and minimize gastrointestinal side effects. Subjects may receive their first injection during an in-person study visit, during which study staff will provide instruction on proper injection technique and answer any questions. Participants will initiate treatment at 0.25 mg weekly for Weeks 1-4 and increase to 0.5 mg weekly for Weeks 5-8, consistent with FDA-approved dosing recommendations. Importantly, the study is not designed to promote weight loss, and weight-related outcomes are monitored solely for safety.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants in this single arm, open-label pilot trial will receive semaglutide administered as a once-weekly subcutaneous injection for 8 weeks. Participants will complete five in-person study visits over 9 weeks. Study visits will include interviews, questionnaires, and collection of biological samples for laboratory testing. Pre- and post-treatment fMRI scans will be completed at Visits 2 and 4. Receives: Drug: semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis cue-reactivity
Investigators will measure brain reactivity to smoking vs. neutral images. A whole-brain fixed-effects general linear model (GLM) will be run using image regressors (cannabis, neutral images) and motion confound regressors. The 2-gamma hemodynamic response function will be convolved with square waves defined by the onset-offset of each image presentation. Beta maps comparing smoking with neutral images will be created for each subject. Multiple comparisons will be FDR corrected. Additionally, beta weights for the cannabis image > neutral image contrasts will be extracted from the anterior insula, dACC, DLPFC, and amygdala across all voxels within each ROI.
Measured: Baseline (pre-intervention), 8 weeks
Resting state connectivity
To evaluate connectivity between the insula and dorsal anterior cingulate cortex (dACC; ROIs) investigators will use techniques comparable to published work and preliminary data. Given the investigator's focus on large scale networks, static connectivity patterns of the DMN, SN, and FPN will be compared between visits as a secondary exploratory analysis. These methods will overlap with prior work where ICA was used to evaluate resting networks. The investigators will also determine if the change in coupling at rest relates to the change in brain reactivity to cannabis cues using a linear regression.
Measured: Baseline (pre-intervention), 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start10 Jan 2027 (estimated)
- Primary completion30 Jan 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
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.
- More trials run by Massachusetts General HospitalThe 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
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Jodi Gilman, Massachusetts General Hospital
- Investigators
- Jodi Gilman, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07879612
- Sponsor's protocol ID
- 2026P002063
- Acronym
- S-CUD
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semaglutide for the Treatment of Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT07879612
- Acronym / sponsor ID
- S-CUD / 2026P002063
- Conditions
- Cannabis Use Disorder, Cue-reactivity
- Keywords
- Semaglutide, Cannabis use disorder, Cue-reactivity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 10 Jan 2027 (estimated)
- Primary completion
- 30 Jan 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 19 Oct 2026 (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 this pilot study is to learn about the effects of semaglutide on brain reactivity to cannabis-related cues in adults with cannabis use disorder. The main questions it aims to answer are:
- Does semaglutide effect reactivity to cannabis-related cues?
- Does semaglutide safely reduce the frequency of cannabis use?
Participants will complete five in-person study visits over 9 weeks, which will include interviews, questionnaires, and collection of biological samples for laboratory testing. fMRI scans will be completed at two visits. All participants will receive weekly injections of 0.25-0.5 mg semaglutide across 8 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: semaglutideParticipants in this single arm, open-label pilot trial will receive semaglutide administered as a once-weekly subcutaneous injection for 8 weeks. Participants will complete five in-person study visits over 9 weeks. Study visits will include interviews, questionnaires, and collection of biological samples for laboratory testing. Pre- and post-treatment fMRI scans will be completed at Visits 2 and 4. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-60 years, inclusive;
- Use cannabis daily or near daily and have been using cannabis consistently for at least the past year, by self-report;
- Diagnosed with moderate to severe DSM-5 cannabis use disorder
- Access to a mobile device to complete daily surveys
- Desire to quit or reduce cannabis consumption
Key exclusion criteria (22 listed)
- Active psychosis, active suicidality (current suicidal ideation with specific plan or intent) or homicidality, suicide attempt or psychiatric hospitalization in the past year, or any psychiatric condition that may impair ability to provide informed consent.
- Any current or lifetime diagnosis of eating disorders including anorexia, bulimia, or binge eating;
- Any current substance use disorder other than cannabis or mild alcohol use disorder;
- BMI <21 kg/m2;
- MRI contraindications (including presence of metallic foreign bodies such as cardiac pacemakers, perfusion pumps, aneurysm clips, metallic tattoos anywhere on the body, tattoos near the eye);
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 |
|---|---|---|
| semaglutideAll participants will receive open-label semaglutide for 8 weeks. Semaglutide will be self-administered as a once-weekly subcutaneous injection according to standard clinical titration procedures to maximize tolerability and minimize gastrointestinal side effects. Subjects may receive their first injection during an in-person study visit, during which study staff will provide instruction on proper injection technique and answer any questions. Participants will initiate treatment at 0.25 mg weekly for Weeks 1-4 and increase to 0.5 mg weekly for Weeks 5-8, consistent with FDA-approved dosing recommendations. Importantly, the study is not designed to promote weight loss, and weight-related outcomes are monitored solely for safety. | Drug | Semaglutide |
Primary outcome
Cannabis cue-reactivity
Time frame: Baseline (pre-intervention), 8 weeks
Investigators will measure brain reactivity to smoking vs. neutral images. A whole-brain fixed-effects general linear model (GLM) will be run using image regressors (cannabis, neutral images) and motion confound regressors. The 2-gamma hemodynamic response function will be convolved with square waves defined by the onset-offset of each image presentation. Beta maps comparing smoking with neutral images will be created for each subject. Multiple comparisons will be FDR corrected. Additionally, beta weights for the cannabis image > neutral image contrasts will be extracted from the anterior insula, dACC, DLPFC, and amygdala across all voxels within each ROI.
Resting state connectivity
Time frame: Baseline (pre-intervention), 8 weeks
To evaluate connectivity between the insula and dorsal anterior cingulate cortex (dACC; ROIs) investigators will use techniques comparable to published work and preliminary data. Given the investigator's focus on large scale networks, static connectivity patterns of the DMN, SN, and FPN will be compared between visits as a secondary exploratory analysis. These methods will overlap with prior work where ICA was used to evaluate resting networks. The investigators will also determine if the change in coupling at rest relates to the change in brain reactivity to cannabis cues using a linear regression.
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 19 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Jodi Gilman, PhD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing semaglutide in people with Cannabis Use Disorder and Cue-reactivity, run by Massachusetts General Hospital.
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 6 inclusion and 22 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Jodi Gilman, PhD (617-643-7293, jgilman1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis cue-reactivity (time frame: Baseline (pre-intervention), 8 weeks). 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 19 Oct 2026.