2023-503371-25-00进行中（未招募）2 期
Does the Glucagon-like Peptide 1 (GLP-1) receptor agonist semaglutide reduce alcohol intake in patients with Alcohol Use Disorder and comorbid obesity?
Psykiatrisk Center Kobenhavn1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年5月12日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days* , after 26 weeks of treatment adjusted for baseline (percentage points (pp)). The 30-day period will be the 30 consecutive days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol intake) out of the 40 days prior to the evaluation, measured by the TLFB method
研究概览
简要总结
Does the glucagon-like peptide 1 (glp-1) receptor agonist semaglutide reduce alcohol intake in patients with alcohol use disorder and comorbid obesity?
研究设计
- 分配方式
- Randomized
- 主要目的
- Intervention (overall period)
- 盲法
- Double (Analyst, Carer, Investigator, Monitor, Subject)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Informed oral and written consent
- •Diagnosed with alcohol dependence according to the criteria of the International Classification of Diseases 10 (ICD-10), and diagnosed with alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
- •Alcohol use disorder identification test (AUDIT) score >15
- •Body mass index (BMI) above or equal to 30 kg/m2
- •Age 18 - 70 years (both included)
- •Heavy alcohol drinking defined as more than 6 days with alcohol consumption over 4 units (48 g alcohol) for women and 5 units (60 g alcohol) for men during a consecutive 30-day period, within 40 days prior to baseline evaluation, measured by the TLFB method. The 30-day period will be the 30 days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol) out of the 40 days.
排除标准
- •Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar disorder or mental retardation
- •Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase > 2 times upper limit)
- •Former medullary thyroid carcinoma (MTC) and/or family history with MTC and/or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- •Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pec-toris and/or myocardial infarction within the last 12 months
- •Uncontrolled hypertension (systolic blood pressure >180 mmHg, diastolic blood pressure >110 mmHg)
- •Concomitant pharmacotherapy against alcohol use disorder i.e. disulfiram, naltrexone, acamprosate, or nalmefene, since the first of the 30 drinking days registered for inclusion at the TLFB-schedule.
- •Receiving any investigational drug within the last three months
- •Use of weight-lowering pharmacotherapy within the preceding 3 months
- •Any other active substance use defined as a DUDIT-score >1 (except nicotine)
- •Hypersensitivity to the active substance or any of the excipients
- •Only for patients undergoing brain scans: Contraindications for undergoing an MRI scan (magnetic implants, pacemaker, claustro-phobia, etc.)
- •A history of delirium tremens or alcohol withdrawal seizures
- •Unable to speak and/or understand Danish
- •Any condition that the investigator feels would interfere with trial participation
- •No serious withdrawal symptoms at inclusion (a score higher than 9 on the Clinical Institute With-drawal Assessment of Alcohol Scale, Revised (CIWA-Ar)) at baseline examinations
- •Present or former neurological disease, including traumatic brain injury
- •Type 1 diabetes, type 2 diabetes in poor glycaemic control (defined as HbA1c ≥48 mmol/l or fasting plasma glucose above 7.0 mmol/l at inclusion)
- •Females of childbearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant within the next 9 months (26 weeks plus three months after discontinuation of semaglutide), or are not using contraceptives (during the whole study period) considered as highly effective (combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) intrauterine device – IUD, IUS, bilateral tubal occlusion, vasectomised partner, sexual abstinence)
- •Pregnancy (serum human chorionic gonadotropin (hCG) > 3 U/L at inclusion)
- •Impaired hepatic function (liver transaminases >3 times the upper limit)
- •Impaired renal function (eGFR < 50 ml/min and/or plasma creatinine >150 µmol/l)
结局指标
主要结局
Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days* , after 26 weeks of treatment adjusted for baseline (percentage points (pp)). The 30-day period will be the 30 consecutive days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol intake) out of the 40 days prior to the evaluation, measured by the TLFB method
Change in alcohol consumption, defined as the change in percentage of heavy drinking days during a period of 30 consecutive days* , after 26 weeks of treatment adjusted for baseline (percentage points (pp)). The 30-day period will be the 30 consecutive days with the biggest alcohol intake (most heavy drinking days and the largest amount of total alcohol intake) out of the 40 days prior to the evaluation, measured by the TLFB method
次要结局
- Change in total alcohol consumption (gram/last 30 consecutive days)
- Change in number of days without alcohol consumption (last 30 consecutive days)
- Change in drinks per day (last 30 consecutive days)
- Time to relapse, defined as the time to first alcohol intake
- Time to first heavy drinking day
- Reduction in WHO alcohol risk level (last 30 consecutive days)
- Change in Penn Alcohol Craving Scale (PACS) score
- Change in Alcohol Use Disorder Identification Test (AUDIT) score
- Change in Drug Use Disorders Identification Test (DUDIT) score
- Change in Fibrosis-4 (FIB4) score
- Change in measures of health (WHOQOL-BREF-score)
- Change in Fagerströms Test for Nicotine Dependence score
- Change in blood gamma-glutamyl transferase (GGT)
- Change in blood alanine transaminase (ALAT)
- Change in plasma levels of phosphatidyl ethanol (PEth)
- Change in blood mean cell volume (MCV)
- Change in body weight
- Change in blood pressure
- Change in pulse
- Change in waist circumference
- Change in glycaemic control parameters (HbA1c)
- Change in brain GABA levels (cortical, caudate, and putamen) assessed by MRS brain scans
- Change in brain alcohol cue-response in reward-processing brain regions (ventral and dorsal striatum, putamen, nucleus accumbens, and caudate), including the septal area assessed by fMRI brain scans
- Change in heavy drinking days during a period of 30 consecutive days measured by the TLFB, after 26 weeks of treatment adjusted for baseline (percentage points (pp)) and maximum tolerable semaglutide dose given.
- Change in heavy drinking days during a period of 30 consecutive days measured by the TLFB, after 26 weeks of treatment adjusted for baseline (percentage points (pp)) and weight loss during the 26 weeks of treatment.
研究者
Anders Fink-Jensen
Scientific
Psykiatrisk Center Kobenhavn
研究点 (1)
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