New treatment option for Cannabis Use Disorder
Official title Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
ClinicalTrials.gov ID: NCT07523633
What this study is testing
What is semaglutide?
semaglutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for cannabis use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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.
- Type 1 diabetes and type 2 diabetes.
- Pregnant or potentially pregnant women: Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, planning to become pregnant within...
See the full eligibility 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.
- Ability to comply with study procedures and follow-up.
- 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.
- Type 1 diabetes and type 2 diabetes.
- 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...
- Impaired liver function (liver transaminases \>3 times the upper reference limit)
- Impaired renal function (eGFR \ 150 µmol/L).
- Impaired pancreatic function (past or current acute or chronic pancreatitis and/or amylase \>2 times the upper limit).
- History of medullary thyroid carcinoma (MTC) and/or family history of MTC and/or Multiple Endocrine Neoplasia type 2 (MEN 2).
- 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.
- Uncontrolled hypertension (systolic blood pressure \>180 mmHg, diastolic blood pressure \>110 mmHg).
- Receipt of experimental medication within the past 30 days.
- Use of weight-loss medication within the past 3 months.
- Hypersensitivity to the active substance or any of the excipients.
- For patients undergoing brain scanning only: Contraindications to MRI scanning (magnetic implants, pacemaker, claustrophobia, etc.).
- Inability to speak and/or understand Danish.
- Other conditions: Any other condition that, in the investigator's opinion, may interfere with participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Frederiksberg, Denmark
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Frederiksberg, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.