EUCTR2016-003343-11-DK进行中（未招募）1 期
Does Glucagon-like Peptide 1 (GLP-1) receptor stimulation reduce alcohol intake in patients with alcohol dependence?
Psychiatric Centre Copenhagen0 个研究点目标入组 169 人开始时间: 2017年1月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 169
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Informed oral and written consent
- •Diagnosed with alcohol dependence according to the criteria of International Classification of Dis-eases (ICD) 10, World Health Organization and DSM-5
- •Alcohol use disorder identification test (AUDIT) score >15 (29)
- •Age 18 - 70 years
- •Heavy alcohol drinking defined as having alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) for at least 5 days in the past 30 days prior to inclusion measured by the TLFB method.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 59
排除标准
- •Severe psychiatric disease, defined as a diagnosis of schizophrenia, paranoid psychosis, bipolar dis-order or mental retardation
- •A history of delirium tremens or alcohol withdrawal seizures
- •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 or HbA1c =48 mmol/l at inclusion
- •Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant or are not using contraceptive measures considered as highly effective (30)
- •Impaired hepatic function (liver transaminases >3 times upper normal limit)
- •Impaired renal function (se-creatinine >150 µM and/or macro albuminuria)
- •Impaired pancreatic function (any history of acute or chronic pancreatitis and/or amylase > 2 times upper limit)
- •S-triglycerides >10 mmol/l.
- •Former medullary thyroid carcinoma (MTC) and/or family history with MTC and/or Multiple Endo-crine 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 dependence including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 1 months prior to inclusion
- •Concomitant pharmacotherapy with dopamine active drugs, such as some types of Attention Defi-cit Hyperactivity Disorder (ADHD) medication (methylphenidat).
- •Receiving any investigational drug within the last 3 months
- •Use of weight-lowering pharmacotherapy within the preceding 3 month
- •Any other active substance use defined as a DUDIT-score > 6 (for men) >2 (for women) and fulfilling the criterias for dependence of the substance according to the criteria of International Classifica-tion of Diseases (ICD) 10 (except nicotine)
- •BMI <18,5 kg/m2
- •Contraindications for undergoing a fMRI scan (magnetic implants, pacemaker, claustrophobia etc.)
- •Contraindications for undergoing a SPECT-scan: radiation exposure, excluding background radia-tion but including diagnostic x-rays and other medical exposures, exceeding 10 mSv in the last 12 months
- •Allergy towards iodine.
- •Unable to speak and/or understand Danish
- •Any condition that the investigator feels would interfere with trial participation
研究者
相似试验
招募中
1 期
SEMALCOAlcohol Use DisorderCTIS2023-503371-25-00Psykiatrisk Center Kobenhavn108
尚未招募
2 期
SemaPsychiatrySchizophrenia2024-518746-24-00Psykiatrisk Center Kobenhavn104
进行中（未招募）
1 期
A study to evaluate the effect of a licensed drug to lower blood glucose, liraglutide, on inflammation in patients with diabetic kidney disease.EUCTR2012-005482-12-IEniversity College Dublin
进行中（未招募）
1 期
GLP-1 and persons without stroke.EUCTR2016-001221-14-DKHerlev Gentofte Hospital
进行中（未招募）
1 期
GLP-1 and strokeMedDRA version: 19.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersStrokeEUCTR2016-001219-18-DKHerlev Gentofte Hospital30