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.
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.
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.
Parallel
semaglutide
Drugsemaglutide (Wegovy) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg.
Placebo
Drugonce-weekly by subcutaneous injection of saline (BD Posiflush)
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.
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)
Cannabis consumption
Cannabis-free days over the past 28 days, assessed using self-reported TLFB.
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.
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.
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Anders Fink-Jensen, MD, DMSci
Lead sponsor
Psychiatric Centre Rigshospitalet
Sponsor institution
