Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
Led by Anders Fink-Jensen, MD, DMSci · Updated on 2026-05-14
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the medicine semaglutide can help adults with cannabis use disorder reduce their cannabis use. This randomized, double-blind, placebo-controlled Phase 2 study will compare semaglutide to a placebo to see if it lowers cannabis consumption. The study also explores how brain activity changes in response to cannabis cues using functional brain scans in some participants. Participants will receive weekly injections of either semaglutide, titrated up to 2.4 mg, or a saline placebo for 20 weeks. The first 50 participants may have functional MRI scans at the start and end of treatment to observe brain responses. All participants will also take part in four supportive therapy sessions. After the 20-week treatment period, a follow-up visit will be conducted at week 46. During the study, cannabis use and other measures such as cannabis metabolites, craving, mood, sleep quality, alcohol and drug use severity, body weight, metabolic risk, and cardiovascular and glycemic parameters will be assessed at multiple time points. Blood and urine samples will be collected for safety and secondary outcomes. Researchers will monitor cannabis consumption as the primary outcome from baseline to week 20, with additional assessments continuing through the follow-up period.
CONDITIONS
Brief Title
Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed oral and written consent
- Diagnosed with cannabis use disorder according to DSM-5 or ICD-10
- Currently seeking to reduce or stop cannabis use
- Positive urine test for cannabinoids
- Body mass index (BMI) of 23 kg/m² or higher
- Aged between 18 and 70 years
- Used cannabis on 16 or more days in the past 28 days
- Consumed cannabis equivalent to at least 14 grams of THC in the past 28 days
- Able to comply with study procedures and follow-up
You will not qualify if you...
- Current non-cannabis or tobacco substance use disorder
- Severe psychiatric illness diagnosis in past 5 years (such as schizophrenia or bipolar disorder)
- Suicide attempt or suicidal behavior in past 5 years
- Severe neurological disorders like serious brain injury or stroke
- Type 1 or type 2 diabetes
- Pregnant or potentially pregnant women, including those planning pregnancy or not using effective contraception
- Impaired liver function (liver enzymes over 3 times normal)
- Impaired kidney function (eGFR under 50 ml/min or high plasma creatinine)
- Past or current pancreatitis or high amylase levels
- History or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia type 2
- Recent serious heart disease or unstable angina
- Uncontrolled high blood pressure
- Use of experimental drugs in past 30 days
- Use of weight-loss medication in past 3 months
- Allergy to semaglutide or any ingredients in the study drug
- For brain scan participants: contraindications to MRI (such as magnetic implants or claustrophobia)
- Unable to speak or understand Danish
- Any other condition that may interfere with study participation according to the investigator's judgment
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive weekly injections of semaglutide or placebo for 20 weeks and attend four supportive therapy sessions during this period.
Weekly visits for injections and 4 therapy sessions
Duration - Approximately 26 weeks after treatment
Participants have a follow-up visit to assess outcomes after treatment ends.
1 visit (in-person) at week 46
Trial Site Locations
Total: 1 location
1
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, Denmark, 2100
Actively Recruiting
Research Team
M
Maria E Marstrand, MD
A
Anders Fink-Jensen, MD, DMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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