Does stimulation of the receptor for Glucagon-like Peptide 1 (GLP-1) reduce alcohol intake in patients with alcohol dependence?

Phase 1

• Conditions: Alcohol dependence; MedDRA version: 20.0Level: LLTClassification code 10001125Term: AddictionSystem Organ Class: 100000004873; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2016-003343-11-DK
• Lead Sponsor: Psychiatric Centre Copenhagen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-27
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

•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

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 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified