A Randomized, Double-Blind, Placebo-Controlled Trial of Semaglutide for Reducing Cannabis Use in Adults With Cannabis Use Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Cannabis consumption
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed oral and written consent.
- •Meets the criteria for cannabis use disorder (CUD) according to DSM-5 or ICD-
- •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.
排除标准
- •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.
- •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.
研究组 & 干预措施
Placebo (saline injection)
Saline once-weekly by subcutaneous injection
干预措施: Placebo (Drug)
semaglutide
Wegovy (semaglutide) once-weekly by subcutaneous injection, titrated to a maximum dose of 2.4 mg
干预措施: semaglutide (Drug)
结局指标
主要结局
Cannabis consumption
时间窗: 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.
次要结局
- 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.)
- Cannabis craving(From baseline to week 20.)
- Depression symptoms(From baseline to week 20.)
- Subjective sleep quality(From baseline to week 20.)
- Severity of alcohol use(From baseline to week 20.)
- Severity of drug use(From baseline to week 20.)
- Drug use frequency(From baseline to week 20.)
- Severity of nicotine(From baseline to week 20.)
- Average Daily Cigarette Consumption(From baseline to week 20.)
- Changes in Quality of life(From baseline to week 20.)
- Body weight(From baseline to week 20.)
- Body fat and metabolic risk(From baseline to week 20.)
- Quantitative measure of nicotine intake(From baseline to week 20.)
- Cardiovascular parameters(From baseline to week 20.)
- Glycaemic parameters(From baseline to week 20.)
- Neural responses in brain regions associated with reward processing(From baseline to week 20.)
- Functional connectivity between NAc/septal regions and prefrontal cortex(From baseline to week 20.)
- Functional connectivity between NAc/septal regions and amygdala/insula(From baseline to week 20.)
研究者
Anders Fink-Jensen, MD, DMSci
Principal Investigator: Anders Fink-Jensen, MD, DMSc, Professor, Mental Health Service Centre Copenhagen , Frederiksberg Hospital, NP Lab
Psychiatric Centre Rigshospitalet