Does Treatment With GLP-1 Reduce Alcohol Intake in Patients With Alcohol Dependence? (EXALT)
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|ClinicalTrials.gov Identifier: NCT03232112|
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : February 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Alcohol Dependence, in Remission Addiction, Alcohol||Drug: Exenatide 2 MG Injection Drug: BD PosiFlush (saline)||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||139 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Double-blinded, randomized, placebo-controlled.|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||An un-blinded nurse will be responsible for carrying out the randomization of the patients in REDCap. When randomization is carried out, the nurse will ensure that the patient gets the treatment that he/she is allocated to. Patients, investigators, other care givers performing assessments and persons performing data analysis will remain blinded from the time of randomization until time of database unlock. In order to maintain the blinding of the patients, the nurse will prepare the injection in a separate room and the patients will be blindfolded as the injection is given.|
|Official Title:||Does Glucagon-like Peptide (GLP-1) Receptor Agonist Stimulation Reduce Alcohol Intake in Patients With Alcohol Dependence?|
|Actual Study Start Date :||July 12, 2017|
|Estimated Primary Completion Date :||July 1, 2019|
|Estimated Study Completion Date :||July 1, 2019|
Active Comparator: Exenatide 2 MG Injection
Bydureon® (exenatide) is supplied as powder and solvent for prolonged release injection (once-weekly). Bydureon® is delivered in a carton containing four pens. Each single-dose, dual-chamber pen contains 0.65 ml of diluent and 2 mg of exenatide, which are isolated until mixed by the person administering the drug. Needles are supplied with the pen.
Drug: Exenatide 2 MG Injection
Subcutaneous injection once-weekly
Other Name: Bydureon Pen, 2 Mg, Extended Release
Placebo Comparator: BD PosiFlush (saline)
The placebo will be supplied for as pre-filled saline syringes (BD PosiFlush™, BD Worldwide) containing 3 ml each. Needles are bought separately.
Drug: BD PosiFlush (saline)
Subcutaneous injection once-weekly
Other Name: Saline
- Heavy drinking days [ Time Frame: 30 days prior to baseline and 30 days prior to final follow up at 26 weeks ]Percent reduction in alcohol consumption, defined as total number of heavy drinking days (as days with an excess intake of 60/48 grams of alcohol per day (men and women, respectively)) for the past 30 days. This will be registered via the Timeline-Follow-Back (TLFB) method.
- Total alcohol consumption [ Time Frame: 30 days prior to baseline and 30 days prior to final follow up at 26 weeks ]Percent reduction in alcohol consumption, defined as "x" grams of alcohol for the past 30 days. This will be registered via the Timeline-Follow-Back (TLFB) method.
- Penn Alcohol Craving Scale (PACS) score [ Time Frame: Baseline and 26 weeks ]Score for measuring alcohol craving
- Alcohol Use Disorders Identification Test (AUDIT) score [ Time Frame: Baseline and 26 weeks ]Screening for excessive drinking
- Drug Use Disorders Identification Test (DUDIT) score [ Time Frame: Baseline and 26 weeks ]A parallel instrument to the AUDIT for identification of individuals with drug-related problems
- Screen For Cognitive Impairment in Psychiatry (SCIP) test [ Time Frame: Baseline, 4 weeks and 26 weeks ]The 20 minute test is a simple scale developed for screening cognitive deficits
- Plasma-gamma-glutamyltransferase (GGT) [ Time Frame: Baseline and 26 weeks ]Liver parameter
- Plasma-alanine aminotransferase (ALAT) [ Time Frame: Baseline and 26 weeks ]Liver parameter
- Plasma-phosphatidylethanol (PEth) [ Time Frame: Baseline, 4, 12, 20 and 26 weeks ]Biomarker for alcohol consumption
- Blood-mean cell volume [ Time Frame: Baseline and 26 weeks ]Measure of the average volume of a red blood cell
- Body weight [ Time Frame: Baseline, 4, 12, 20 and 26 weeks ]Body weight in kilograms
- Blood pressure [ Time Frame: Baseline, 4, 12, 20 and 26 weeks ]Systolic and diastolic blood pressure
- Pulse [ Time Frame: Baseline, 4, 12, 20 and 26 weeks ]Number of heartbeats pr. minute
- Waist circumference [ Time Frame: Baseline, 4, 12, 20 and 26 weeks ]Widest abdominal circumference in centimeters
- Plasma-glycemic control parameters [ Time Frame: Baseline and 26 weeks ]HbA1c, cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL).
- Kidney function [ Time Frame: Baseline and 26 weeks (eGFR also at week 12) ]e-GFR, urine albumine/creatinine-ratio.
- Short Form Health Survey (SF-36) [ Time Frame: Baseline and 26 weeks ]36-item, patient-reported survey of patient health
- Plasma amylase [ Time Frame: Baseline and 26 weeks ]Safety (i.e. pancreatic function)
- Symptom Checklist (SCL-92) [ Time Frame: Baseline and 26 weeks ]92-item, patient-reported survey of a broad range of psychological problems and symptoms of psychopathology.
- Single-photon emission computed tomography (SPECT) [ Time Frame: Baseline and 26 weeks ]In this study we want to investigate whereas GLP-1 receptor stimulation induces changes in the striatal dopamine transporter availability in humans.
- fMRI (functional magnetic resonance imaging) [ Time Frame: Baseline and 26 weeks ]In this study we want to investigate whereas GLP-1 treatment modulate neural responses in reward processing regions including nucleus accumbens. Data from the 25 healthy participants will be used as comparable standard when analyzing the data.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03232112
|Contact: Anders Fink-Jensen, MD, DMSci||+45 email@example.com|
|Contact: Mette K Klausen, MD||+45 firstname.lastname@example.org|
|Copenhagen, Frederiksberg, Denmark, 2000|
|Contact: Henrik Rindom, MD +45 22658087 email@example.com|
|Contact: Mette K Klausen, MD +45 22649599 firstname.lastname@example.org|
|Principal Investigator:||Henrik Rindom, MD||The Novavi outpatient clinics, Copenhagen|