Status:
COMPLETED
Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence?
Lead Sponsor:
Anders Fink-Jensen, MD, DMSci
Collaborating Sponsors:
The Novavì outpatient clinics, Copenhagen
Neurobiology Research Unit, Rigshospitalet, Copenhagen
Conditions:
Alcohol Dependence, in Remission
Addiction, Alcohol
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief 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....
Detailed Description
Number of patients and target population: 144 patients with a diagnosis of alcohol dependence and 25 healthy participants (described later). The patients included in the trial will be treated for 26...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2020
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03232112
Start Date
August 7 2017
End Date
October 5 2020
Last Update
June 4 2021
Active Locations (1)
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1
Novavì ambulatorierne
Copenhagen, Frederiksberg, Denmark, 2000