Semaglutide for cannabis use disorder: see if a medicine helps reduce use

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 2, randomized, double-blind trial, adults with cannabis use disorder receive either semaglutide or placebo for 20 weeks, with a follow-up at 46 weeks. The study includes 100 participants and extra brain imaging for up to 50 participants to explore brain responses to cannabis cues. Participants also receive four supportive therapy sessions and regular assessments at multiple time points. Primary outcome is reduction in cannabis use by week 20, with secondary outcomes including brain activity changes and safety measures.

Why it matters

Who can join: the full rules

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 five years.
3. Suicide attempt or suicidal behavior within the past five years.
4. Severe neurological disorders, including previous severe traumatic brain injury, stroke, or intracranial hemorrhage.
5. Type 1 diabetes and type 2 diabetes.
6. 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.
7. Impaired liver function (liver transaminases \>3 times the upper reference limit)
8. Impaired renal function (eGFR \<50 ml/min and/or plasma creatinine \>150 µmol/L).
9. Impaired pancreatic function (past or current acute or chronic pancreatitis and/or amylase \>2 times the upper limit).
10. History of medullary thyroid carcinoma (MTC) and/or family history of MTC and/or Multiple Endocrine Neoplasia type 2 (MEN 2).
11. Heart disease is defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, and/or myocardial infarction within the past 12 months.
12. Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>110 mmHg).
13. Receipt of experimental medication within the past 30 days.
14. Use of weight-loss medication within the past 3 months.
15. Hypersensitivity to the active substance or any of the excipients.
16. For patients undergoing brain scanning only:

    Contraindications to MRI scanning (magnetic implants, pacemaker, claustrophobia, etc.).
17. Inability to speak and/or understand Danish.
18. Other conditions: Any other condition that, in the investigator's opinion, may interfere with participation in the trial.

Where it's running

• Psychiatric Center Copenhagen, Frederiksberg Hospital
  Frederiksberg, Denmark Recruiting

Study contacts

• Study coordinator: Maria E Marstrand, MD
• Email: maria.erlang.marstrand@regionh.dk
• Phone: +4520896532

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Brain imaging to predict teens' response to cannabis treatment

  This project will test whether teens' brain activity during a learning task can predict how well 14–17-year-olds do in a 10-week virtual reward program to reduce cannabis use.

  Recruiting Indiana University · Indianapolis, Indiana · NCT07340554

• 12-week aerobic exercise program for people using cannabis

  This program will try a 12-week indoor cycling regimen to see if regular exercise reduces cannabis dependence and the severity of cannabis use disorder in adults aged 18–40.

  Recruiting The University of Hong Kong · Hong Kong · NCT07091292

• Investigating cognitive function in psychosis patients and cannabis users

  This study is testing how taking a break from cannabis for 28 days affects thinking skills and brain activity in people with psychosis and those who use cannabis but don’t have mental health issues.

  Recruiting Douglas Mental Health University Institute · Montreal, Quebec · NCT05445180

• Can tACS modulate motivation and reward signals in cannabis use disorder and depression

  We’re testing whether a gentle brain stimulation method (tACS) can boost motivation and reward responses in adults with cannabis use and/or depression to see if it helps with anhedonia.

  Recruiting Florida State University · Tallahassee, Florida and 1 other locations · NCT07924852

• Sex differences in how cannabis affects people who regularly use it

  This Phase 2 trial tests whether men and women who use cannabis several days a week respond differently to THC versus placebo.

  Recruiting Phase 2 Medical University of South Carolina · Charleston, South Carolina · NCT07815691

• Reducing cannabis use to improve daily functioning.

  This program will try an 8-week combination of motivational interviewing, computerized CBT (CBT4CBT), and small financial rewards to help adults with cannabis use disorder cut back on cannabis.

  Recruiting Medical University of South Carolina · Charleston, South Carolina · NCT07218471

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.