Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?

• Status: Completed
• Trial end date: 2020-10-05
• Target enrollment: 0
• Participant gender: All

Summary

The study is a double-blinded, randomized, placebo-controlled, 26-weeks clinical trial. The objective of the trial is to investigate the effects of the GLP-1 receptor agonist Bydureon® (exenatide) vs. placebo on alcohol intake in patients with a diagnosis of alcohol dependence.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Anders Fink-Jensen, MD, DMSci
• Collaborators: Neurobiology Research Unit, Rigshospitalet, Copenhagen; Section of Biostatistics University of Copenhagen, Copenhagen; The Novavì outpatient clinics, Copenhagen
• Treatments: Calcium heparin; Ethanol; Exenatide; Glucagon; Heparin

Criteria

Inclusion Criteria:

• Informed oral and written consent

• Diagnosed with alcohol dependence according to the criteria of International Classification of Diseases (ICD) 10, World Health Organization and DSM-5

• Alcohol use disorder identification test (AUDIT) score >15

• 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.

Exclusion Criteria:

• 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 Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar)) at baseline examinations

• Present or former neurological disease including traumatic brain injury

• Present or former diagnosis of type 1 or type 2 diabetes or plasma Haemoglobin A1c (HbA1c ) ≥48 moll/L at inclusion

• Females of child bearing potential who are pregnant, breast-feeding or have intention of becoming pregnant within the next 9 months (26 weeks plus three months after discontinuation of Bydureon®) , 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) (33)

• Pregnancy (serum hCG > 3 at inclusion) Impaired hepatic function (liver transaminases >3 times up-per normal limit)

• Impaired renal function (eGFR < 50 ml/min and/or microalbuminuria) 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 pectoris 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 month prior to inclusion

• Concomitant pharmacotherapy with dopamine active drugs, such as some types of Attention Deficit Hyperactivity Disorder (ADHD) medication (methylphenidate)

• 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 criteria's for dependence of the substance according to the criteria of International Classification of Diseases (ICD) 10 (except nicotine)

• BMI <18.5 kg/m2

• Hypersensitivity to the active substance or to any of the excipients

• Only for patients undergoing brain scans: Contraindications for undergoing an fMRI scan (magnetic implants, pacemaker, claustrophobia etc.). Contraindications for undergoing a SPECT-scan (allergy towards iodine, radiation exposure, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 10 mSv in the last 12 months)

• Unable to speak and/or understand Danish

• Any condition that the investigator feels would interfere with trial participation