Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
HASHTAG
A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
3 other identifiers
interventional
100
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
April 30, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2028
May 14, 2026
May 1, 2026
2 years
March 30, 2026
May 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cannabis consumption
Total cannabis consumption (grams) over the last 28 days, measured using the Timeline Follow-back (TLFB) after 20 weeks of treatment and adjusted for baseline.
From baseline to week 20.
Secondary Outcomes (23)
Quantitative measure of cannabis metabolites
From baseline to week 20.
Cannabis consumption
From baseline to week 20.
THC consumption
From baseline to week 20.
Severity of cannabis use
From baseline to week 20.
Cannabis problems
From baseline to week 20.
- +18 more secondary outcomes
Study Arms (2)
semaglutide
EXPERIMENTALWegovy (semaglutide) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg
Placebo (saline injection)
PLACEBO COMPARATORSaline once-weekly by subcutaneous injection
Interventions
semaglutide (Wegovy) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg.
Eligibility Criteria
You may qualify 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.
- 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.
You may not qualify 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.
- Impaired liver function (liver transaminases \>3 times the upper reference limit)
- Impaired renal function (eGFR \<50 ml/min and/or plasma creatinine \>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:
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator: Anders Fink-Jensen, MD, DMSc, Professor, Mental Health Service Centre Copenhagen , Frederiksberg Hospital, NP Lab
Study Record Dates
First Submitted
March 30, 2026
First Posted
April 13, 2026
Study Start
April 30, 2026
Primary Completion (Estimated)
April 30, 2028
Study Completion (Estimated)
April 30, 2028
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
IPD will be shared upon reasonable relevant requests, e.g. for meta-analyses or independent validations. IPD will be shared anonymized or de-identified to protect participants' privacy and in accordance with relevant regulations (GDPR).