A Phase 2 interventional study of semaglutide in Cannabis Use Disorder and Cue-reactivity, sponsored by Massachusetts General Hospital. Not yet recruiting. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Massachusetts General Hospital · Phase 2, Interventional, and Basic science
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:
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.
Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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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.
Drug: semaglutide
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.
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.
Time frame: 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.
Time frame: Baseline (pre-intervention), 8 weeks
No study locations are listed for this record.
Plan to share: Yes
Access criteria: For data inquiries, please email Jodi Gilman at jgilman1@mgh.harvard.edu. A data use agreement and IRB approval will be required.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jan 2029, 24 months later.
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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Semaglutide
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