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Study of semaglutide to reduce cannabis use in adults with cannabis use disorder

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study aims to investigate the effect of semaglutide on reducing the use of cannabis in adults with Cannabis Use Disorder. Cannabis Use Disorder is a condition where a person's use of cannabis leads to significant problems in their daily life. Participants in the study will receive either semaglutide, which is sold under the name Wegovy, or a placebo. The medication is administered through a subcutaneous injection, which is a method of delivering medicine by injecting it into the fatty layer of tissue just below the skin.

During the study, participants will follow a specific course involving regular injections. Researchers will look at several factors, such as the amount of cannabis used and changes in biological markers like THC levels in the blood and urine. THC is the main substance in cannabis that causes its effects. Other aspects being monitored include sleep quality, mood, and physical measurements such as body weight and blood pressure.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study participation</b>

    After joining the study, a 20-week treatment period begins.

  2. Step 2

    <b>medication administration</b>

    A subcutaneous injection, which is an injection administered just under the skin, is required. you will receive either a test medication or a placebo.

  3. Step 3

    <b>placebo administration</b>

    If assigned to the placebo, you will receive a saline solution (sodium chloride) via subcutaneous injection at a dose of 0.5 ml.

  4. Step 4

    <b>monitoring and assessment</b>

    Throughout the 20 weeks, various measurements are taken to track changes. these include assessments of cannabis use, body weight, waist circumference, blood pressure, and pulse.

Who can join the trial?

9 criteria

  • You must provide informed consent, which means you agree to participate in the study after being fully explained all the details, risks, and benefits.
  • You must meet the medical definition for Cannabis Use Disorder (CUD), which is a condition where cannabis use leads to significant problems in a person's life.
  • You must be actively trying to reduce or stop using cannabis.
  • You must have a positive urine test for cannabinoids, which are the chemical compounds found in cannabis that show up in your bodily fluids.
  • Your Body Mass Index (BMI), which is a measure of your body weight relative to your height, must be 23 kg/m² or higher.
  • You must be between the ages of 18 and 70 years old.
  • You must have used cannabis frequently in the recent past, specifically on 16 or more days during the last 28 days.
  • Your recent cannabis use (whether smoked, vaped, or eaten) must be equal to at least 14 grams of THC, the main active ingredient in cannabis, over the last 28 days.
  • You must be able to follow all the rules and steps of the study and attend all scheduled check-ups.

Who cannot join the trial?

19 criteria

  • You have a substance use disorder (an addiction or problematic use) involving any drug or substance other than cannabis or tobacco.
  • You have a history of, or a family history of, medullary thyroid carcinoma (a specific type of thyroid cancer) or Multiple Endocrine Neoplasia type 2 (a genetic condition that can cause various tumors).
  • You have heart disease, which includes decompensated heart failure (a condition where the heart cannot pump enough blood to meet the body's needs), unstable angina pectoris (chest pain that is unpredictable or worsening), or have had a myocardial infarction (a heart attack) in the last 12 months.
  • You have uncontrolled hypertension (high blood pressure) where the top number is higher than 180 or the bottom number is higher than 110.
  • You have taken any experimental medication (a drug being tested in a study) within the last 30 days.
  • You have used any weight-loss medication within the last 3 months.
  • You have a hypersensitivity (an allergy or extreme sensitivity) to the active ingredient in the medicine or any of the excipients (inactive ingredients used to make the medicine).
  • If you are having brain scans, you cannot have contraindications to MRI, such as having a pacemaker (a device to control heart rhythm), magnetic implants, or claustrophobia (an extreme fear of enclosed spaces).
  • You are unable to speak or understand the Danish language.
  • The study doctor believes you have any other health condition that might prevent you from safely participating.
  • You have been diagnosed with a severe psychiatric illness, such as schizophrenia, bipolar disorder, or psychoses (conditions that affect how a person perceives reality), within the last five years.
  • You have attempted suicide or engaged in suicidal behavior within the last five years.
  • You have severe neurological disorders, such as a history of traumatic brain injury (serious damage to the brain from an impact), stroke, or intracranial hemorrhage (bleeding inside the skull).
  • You have Type 1 diabetes or Type 2 diabetes.
  • You are pregnant, breastfeeding, planning to become pregnant in the next eight months, or are not using effective contraception (reliable methods to prevent pregnancy).
  • You have a pregnancy test result showing hCG levels (a hormone detected in pregnancy) higher than 3 U/L.
  • You have impaired liver function, which is measured by high levels of liver transaminases (enzymes that leak into the blood when liver cells are damaged).
  • You have impaired renal function (reduced kidney function), indicated by a low eGFR (a measure of how well kidneys filter blood) or high plasma creatinine (a waste product measured in the blood).
  • You have impaired pancreatic function, such as a history of pancreatitis (inflammation of the pancreas) or high levels of amylase (an enzyme produced by the pancreas).
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Investigated drugs

Wegovy is an injectable medication used in this study to investigate whether it can help reduce the use of cannabis in adults who have a cannabis use disorder.

What is already known about the treatment

  • Saline Solution Basi 9 mg/ml

    This substance is a sterile salt-water solution administered through a subcutaneous injection under the skin. It is widely used in medical practice as a neutral liquid to balance fluids or to act as a placebo in clinical trials. Because it contains only salt and water, it does not have a specific therapeutic effect on medical conditions.

  • Semaglutide

    This medication is administered as a subcutaneous injection using a pre-filled pen. It is an established treatment used primarily to manage weight and blood sugar levels in patients. At a molecular level, it mimics a natural hormone that targets areas of the brain to regulate appetite and hunger signals. It belongs to a class of drugs known as glucagon-like peptide-1 receptor agonists.

Investigated diseases

Cannabis use disorder - This condition involves a pattern of cannabis use that leads to significant problems or distress. It often begins with regular use of the substance, which can eventually develop into a loss of control over how much is consumed. As the condition progresses, an individual may experience strong urges or cravings to use cannabis. They might also find it increasingly difficult to stop using it even when it causes issues in their daily life. The pattern can lead to a continued use of the substance despite negative consequences.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524163-21-00Estimated enrolment100 patientsSponsorRegion Hovedstaden

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