Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
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 brai
| Condition(s) | Cannabis Use Disorder, Cannabis Use Disorders, Cannabis Abuse, Cannabis Dependence, Cannabis Addiction |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | Inclusion Criteria: 1. Informed oral and written consent. 2. Meets the criteria for cannabis use disorder (CUD) according to DSM-5 or ICD-10. 3. Currently seeking to cut down or stop cannabis use. 4. Positive urine test for cannabinoids. 5. Body mass index (BMI) ≥ 23 kg/m². 6. Age 18-70 years. 7. Recent frequent cannabis use, defined as use on ≥16 days out of the past 28 days. 8. Cannabis use (smoked, vaped, edibles) equivalent to THC doses of ≥14 grams in the past 28 days before baseline. 9. Ability to comply with study procedures and follow-up. Exclusion Criteria: 1. Currently meeting non-cannabis/tobacco substance use disorder (ICD-10 or DSM-5). 2. Current or past diagnosis of severe psychiatric illness, defined as schizophrenia, bipolar disorder, or other psychoses, within the past fiv |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Anders Fink-Jensen, MD, DMSci |
| Locations | Frederiksberg, Denmark |
| Start date | 2026-04-30 |
| NCT ID | NCT07523633 |
| Official listing | https://clinicaltrials.gov/study/NCT07523633 |