Trials / Not Yet Recruiting
Not Yet RecruitingNCT07523633
Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
- Status
- Not Yet Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Anders Fink-Jensen, MD, DMSci · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The HASHTAG Study is investigating whether the medicine semaglutide can help adults with cannabis use disorder (CUD) reduce their cannabis use. Participants will be randomly assigned to receive either semaglutide or a placebo. The first 50 participants will have functional brain scans (fMRI) to investigate how the brain responds to cannabis-related cues. The main outcome after 20 weeks is whether semaglutide reduces cannabis use compared to placebo. Changes in brain activity in response to cannabis cues will be explored as a secondary outcome.
Detailed description
This is a randomized (1:1), double-blind, placebo-controlled clinical study investigating whether semaglutide reduces cannabis use. Participants will receive weekly injections of semaglutide or placebo for 20 weeks, with the primary endpoint assessed at the end of treatment. A follow-up visit will occur at week 46. A total of 100 participants will be enrolled. Cannabis use and secondary outcomes will be measured at week 0, 6, 12, 20, and 46. Participants will also receive four sessions of supportive therapy. Randomization and blinding: Injections will be administered by staff who are not involved in any other study procedures to maintain the double-blind setup. Optional fMRI sub-study: Up to 50 eligible participants will undergo fMRI scans at baseline and week 20. Blood and urine samples will be collected for safety and secondary endpoints.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | semaglutide | semaglutide (Wegovy) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg. |
| DRUG | Placebo | once-weekly by subcutaneous injection of saline (BD Posiflush) |
Timeline
- Start date
- 2026-04-30
- Primary completion
- 2028-04-30
- Completion
- 2028-04-30
- First posted
- 2026-04-13
- Last updated
- 2026-04-13
Source: ClinicalTrials.gov record NCT07523633. Inclusion in this directory is not an endorsement.