Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder (NCT07523633) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
100 participantsStarted 2026-04-30
Plain-language 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
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Informed oral and written consent.
✓. Meets the criteria for cannabis use disorder (CUD) according to DSM-5 or ICD-10.
✓. Currently seeking to cut down or stop cannabis use.
✓. Positive urine test for cannabinoids.
✓. Body mass index (BMI) ≥ 23 kg/m².
✓. Age 18-70 years.
✓. Recent frequent cannabis use, defined as use on ≥16 days out of the past 28 days.
✓. Cannabis use (smoked, vaped, edibles) equivalent to THC doses of ≥14 grams in the past 28 days before baseline.
Exclusion criteria
✕. Currently meeting non-cannabis/tobacco substance use disorder (ICD-10 or DSM-5).
✕. Current or past diagnosis of severe psychiatric illness, defined as schizophrenia, bipolar disorder, or other psychoses, within the past five years.
✕. Suicide attempt or suicidal behavior within the past five years.
✕. Severe neurological disorders, including previous severe traumatic brain injury, stroke, or intracranial hemorrhage.
. Pregnant or potentially pregnant women: Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, planning to become pregnant within the next eight months (including 20 weeks of treatment plus two months after discontinuation of semaglutide), or not using effective contraception throughout the study period. Effective methods include combined hormonal contraception (oral, intravaginal, transdermal), progestogen-only hormonal contraception (oral, implant, injection), intrauterine device/system (IUD/IUS), bilateral tubal occlusion, partner with vasectomy, or sexual abstinence. WOCBP with a measured serum human chorionic gonadotropin (hCG) level \>3 U/L at inclusion will also be excluded.
✕. Impaired liver function (liver transaminases \>3 times the upper reference limit)