Cannabis Use DisorderPhase 2HASHTAGNCT07523633
Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder
A Phase 2 study testing semaglutide in people with Cannabis Use Disorder and Cannabis Use Disorders, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cannabis Use Disorder, Cannabis Use Disorders, Cannabis Abuse
- What is being tested?
- semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Apr 2026to 30 Apr 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 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.
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- 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:
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, 2100
Maria Marstrand E MD, Ph.d.-student, MD, +4529354369, maria.erlang.marstrand@regionh.dk
Anders Fink-Jensen, MD, DMSc, +4522755843, anders.fink-jensen@regionh.dk
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
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.
Read the detailed description
This is a randomized (1:1), double-blind, placebo-controlled clinical study investigating whether semaglutide reduces cannabis use. Participants will receive weekly injections of semaglutide or placebo for 20 weeks, with the primary endpoint assessed at the end of treatment. A follow-up visit will occur at week 46.
A total of 100 participants will be enrolled. Cannabis use and secondary outcomes will be measured at week 0, 6, 12, 20, and 46. Participants will also receive four sessions of supportive therapy.
Randomization and blinding: Injections will be administered by staff who are not involved in any other study procedures to maintain the double-blind setup.
Optional fMRI sub-study: Up to 50 eligible participants will undergo fMRI scans at baseline and week 20. Blood and urine samples will be collected for safety and secondary endpoints.
- Conditions
- Cannabis Use Disorder, Cannabis Use Disorders, Cannabis Abuse, Cannabis Dependence, Cannabis Addiction
- Being tested
- semaglutide, Placebo
- Keywords
- GLP-1, Glucagon-like peptide 1, semaglutide, fMRI, cannabis, GLP-1 receptor agonist, Randomized Controlled Trial, Double-Blind Method, Placebo-Controlled, Neuroimaging, Brain activity, Cue reactivity, Craving, Drug therapy
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
semaglutide (Wegovy) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg.
PlaceboDrug
once-weekly by subcutaneous injection of saline (BD Posiflush)
| Study group | Role | What they receive |
|---|---|---|
| semaglutide | Experimental | Wegovy (semaglutide) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg Receives: Drug: semaglutide |
| Placebo (saline injection) | Placebo comparator | Saline once-weekly by subcutaneous injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to week 20.
Secondary outcomes (23)
Quantitative measure of cannabis metabolites
Change in plasma and urine concentrations of THC and its metabolites (11-hydroxy-delta 9-tetrahydrocannabinol (11-OH-THC) and 11-nor-9-carboxy-delta 9-tetrahydrocannabinol (THCCOOH) levels)
Measured: From baseline to week 20.
Cannabis consumption
Cannabis-free days over the past 28 days, assessed using self-reported TLFB.
Measured: From baseline to week 20.
THC consumption
Total THC consumption, measured in standard THC units over 28 days after 20 weeks of treatment, assessed using TLFB and adjusted for baseline.
Note: Total THC consumption is calculated based on grams used, method of administration, and average THC concentration from seized cannabis in DK.
Measured: From baseline to week 20.
Severity of cannabis use
Change in Cannabis Use Disorders Identification Test - Revised (CUDIT-R) score. Minimum score = 0, maximum score = 32. A high score means a worse outcome.
Measured: From baseline to week 20.
Cannabis problems
Change in Marijuana Problem Scale (MPS) score. Minimum score = 0, maximum score = 19. A high score means a worse outcome.
Measured: From baseline to week 20.
Cannabis craving
Change in Marijuana Craving Questionnaire - Short Form (MCQ-SF) score. Minimum score = 12, maximum score = 84. A high score means a worse outcome.
Measured: From baseline to week 20.
Depression symptoms
Change in Patient Health Questionnaire - 9 items (PHQ-9) total score. Minimum score = 0, maximum score = 27. A high score means a worse outcome.
Measured: From baseline to week 20.
Subjective sleep quality
Change in Pittsburgh Sleep Quality Index (PSQI) global score. Minimum score = 0, maximum score = 21. A high score means a worse outcome.
Measured: From baseline to week 20.
Severity of alcohol use
Change in Alcohol Use Disorder Identification Test (AUDIT) score. Minimum score = 0, maximum score =40. A high score means a worse outcome.
Measured: From baseline to week 20.
Severity of drug use
Change in Drug Use Disorders Identification Test (DUDIT) score. Minimum score = 0, maximum score =44. A high score means a worse outcome.
Measured: From baseline to week 20.
Drug use frequency
Change in drug use frequency measured using the drug use frequency section of the DUDIT-extended
Measured: From baseline to week 20.
Severity of nicotine
Change in Fagerströms Test for Nicotine Dependence score. Minimum score = 0, maximum score =10. A high score means a worse outcome.
Measured: From baseline to week 20.
Average Daily Cigarette Consumption
Change in mean cigarettes per day on average during the past week
Measured: From baseline to week 20.
Changes in Quality of life
Change in World Health Organization Quality of Life - BREF (WHOQOL-BREF) domain scores. Scores are transformed to a 0 to 100 scale. Higher scores indicate better quality of life (better outcome).
Measured: From baseline to week 20.
Body weight
Percent change in body weight (kilograms)
Measured: From baseline to week 20.
Body fat and metabolic risk
Change in waist circumference (cm)
Measured: From baseline to week 20.
Quantitative measure of nicotine intake
Change in Blood cotinine levels
Measured: From baseline to week 20.
Cardiovascular parameters
Changes in Blood pressure (both systolic and diastolic)
Measured: From baseline to week 20.
Cardiovascular parameters
Change in pulse
Measured: From baseline to week 20.
Glycaemic parameters
Change in HbA1c
Measured: From baseline to week 20.
Neural responses in brain regions associated with reward processing
Change in fMRI cue reactivity using a cannabis paradigm. Measures brain response to cannabis-related cues.
Measured: From baseline to week 20.
Functional connectivity between NAc/septal regions and prefrontal cortex
Resting-state fMRI connectivity analysis
Measured: From baseline to week 20.
Functional connectivity between NAc/septal regions and amygdala/insula
Resting-state fMRI connectivity analysis
Measured: From baseline to week 20.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start30 Apr 2026
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523633
- Sponsor's protocol ID
- The HASHTAG Study
- Other IDs
- U1111-1327-8749, 2025-524163-21, 2025
- Acronym
- HASHTAG
- Status last verified
- May 2026
- First submitted
- 30 Mar 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
- ClinicalTrials.gov ID
- NCT07523633
- Acronym / sponsor ID
- HASHTAG / The HASHTAG Study
- Conditions
- Cannabis Use Disorder, Cannabis Use Disorders, Cannabis Abuse, Cannabis Dependence, Cannabis Addiction
- Keywords
- GLP-1, Glucagon-like peptide 1, semaglutide, fMRI, cannabis, GLP-1 receptor agonist, Randomized Controlled Trial, Double-Blind Method
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized (1:1), double-blind, placebo-controlled clinical study investigating whether semaglutide reduces cannabis use. Participants will receive weekly injections of semaglutide or placebo for 20 weeks, with the primary endpoint assessed at the end of treatment. A follow-up visit will occur at week 46.
A total of 100 participants will be enrolled. Cannabis use and secondary outcomes will be measured at week 0, 6, 12, 20, and 46. Participants will also receive four sessions of supportive therapy.
Randomization and blinding: Injections will be administered by staff who are not involved in any other study procedures to maintain the double-blind setup.
Optional fMRI sub-study: Up to 50 eligible participants will undergo fMRI scans at baseline and week 20. Blood and urine samples will be collected for safety and secondary endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semaglutide | Experimental | Drug: semaglutideWegovy (semaglutide) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg |
| Placebo (saline injection) | Placebo comparator | Drug: PlaceboSaline once-weekly by subcutaneous injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| semaglutidesemaglutide (Wegovy) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg. | Drug | semaglutide |
| Placeboonce-weekly by subcutaneous injection of saline (BD Posiflush) | Drug | Placebo (saline injection) |
Primary outcome
Cannabis consumption
Time frame: From baseline to week 20.
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.
23 secondary outcomes
Quantitative measure of cannabis metabolites
Time frame: From baseline to week 20.
Cannabis consumption
Time frame: From baseline to week 20.
THC consumption
Time frame: From baseline to week 20.
Severity of cannabis use
Time frame: From baseline to week 20.
Cannabis problems
Time frame: From baseline to week 20.
Cannabis craving
Time frame: From baseline to week 20.
Depression symptoms
Time frame: From baseline to week 20.
Subjective sleep quality
Time frame: From baseline to week 20.
Severity of alcohol use
Time frame: From baseline to week 20.
Severity of drug use
Time frame: From baseline to week 20.
Drug use frequency
Time frame: From baseline to week 20.
Severity of nicotine
Time frame: From baseline to week 20.
Average Daily Cigarette Consumption
Time frame: From baseline to week 20.
Changes in Quality of life
Time frame: From baseline to week 20.
Body weight
Time frame: From baseline to week 20.
Body fat and metabolic risk
Time frame: From baseline to week 20.
Quantitative measure of nicotine intake
Time frame: From baseline to week 20.
Cardiovascular parameters
Time frame: From baseline to week 20.
Cardiovascular parameters
Time frame: From baseline to week 20.
Glycaemic parameters
Time frame: From baseline to week 20.
Neural responses in brain regions associated with reward processing
Time frame: From baseline to week 20.
Functional connectivity between NAc/septal regions and prefrontal cortex
Time frame: From baseline to week 20.
Functional connectivity between NAc/septal regions and amygdala/insula
Time frame: From baseline to week 20.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing semaglutide in people with Cannabis Use Disorder and Cannabis Use Disorders, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria E Marstrand, MD (+4520896532, maria.erlang.marstrand@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cannabis consumption (time frame: From baseline to week 20.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.