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Trial · Interventional

CompletedPhase 2Registry data

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

Short name EXALT

Overview

Status
Completed
Phase
Phase 2
Enrollment
152 participants (actual)
Sponsor
Anders Fink-Jensen, MD, DMSci · Other
Design
Randomized · Triple masking
Countries
1 country

Denmark

Start
7 Aug 2017
Primary completion
15 Mar 2020
Completion
5 Oct 2020
First posted
27 Jul 2017
Last update posted
4 Jun 2021
Conditions
Alcohol Dependence, in Remission · Addiction, Alcohol

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 2

    EXALT

    NCT03232112

    7 Aug 2017 to 5 Oct 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Exenatide 2 MG InjectionDrug
  • BD PosiFlush (saline)Drug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Heavy drinking days

    Time frame · 30 days prior to baseline and 30 days prior to final follow up at 26 weeks

    Registry description

    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.

Secondary outcomes(20)
  1. Total alcohol consumption

    Time frame · 30 days prior to baseline and 30 days prior to final follow up at 26 weeks

    Registry description

    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.

  2. Penn Alcohol Craving Scale (PACS) score

    Time frame · Baseline and 26 weeks

    Registry description

    Score for measuring alcohol craving

  3. Alcohol Use Disorders Identification Test (AUDIT) score

    Time frame · Baseline and 26 weeks

    Registry description

    Screening for excessive drinking

  4. Drug Use Disorders Identification Test (DUDIT) score

    Time frame · Baseline and 26 weeks

    Registry description

    A parallel instrument to the AUDIT for identification of individuals with drug-related problems

  5. Screen For Cognitive Impairment in Psychiatry (SCIP) test

    Time frame · Baseline, 4 weeks and 26 weeks

    Registry description

    The 20 minute test is a simple scale developed for screening cognitive deficits

  6. Plasma-gamma-glutamyltransferase (GGT)

    Time frame · Baseline and 26 weeks

    Registry description

    Liver parameter

  7. Plasma-alanine aminotransferase (ALAT)

    Time frame · Baseline and 26 weeks

    Registry description

    Liver parameter

  8. Plasma-phosphatidylethanol (PEth)

    Time frame · Baseline, 4, 12, 20 and 26 weeks

    Registry description

    Biomarker for alcohol consumption

  9. Blood-mean cell volume

    Time frame · Baseline and 26 weeks

    Registry description

    Measure of the average volume of a red blood cell

  10. Body weight

    Time frame · Baseline, 4, 12, 20 and 26 weeks

    Registry description

    Body weight in kilograms

  11. Blood pressure

    Time frame · Baseline, 4, 12, 20 and 26 weeks

    Registry description

    Systolic and diastolic blood pressure

  12. Pulse

    Time frame · Baseline, 4, 12, 20 and 26 weeks

    Registry description

    Number of heartbeats pr. minute

  13. Waist circumference

    Time frame · Baseline, 4, 12, 20 and 26 weeks

    Registry description

    Widest abdominal circumference in centimeters

  14. Plasma-glycemic control parameters

    Time frame · Baseline and 26 weeks

    Registry description

    HbA1c, cholesterol, triglycerides, high-density lipoprotein (HDL), low-density lipoprotein (LDL).

  15. Kidney function

    Time frame · Baseline and 26 weeks (eGFR also at week 12)

    Registry description

    e-GFR, urine albumine/creatinine-ratio.

  16. Short Form Health Survey (SF-36)

    Time frame · Baseline and 26 weeks

    Registry description

    36-item, patient-reported survey of patient health

  17. Plasma amylase

    Time frame · Baseline and 26 weeks

    Registry description

    Safety (i.e. pancreatic function)

  18. Symptom Checklist (SCL-92)

    Time frame · Baseline and 26 weeks

    Registry description

    92-item, patient-reported survey of a broad range of psychological problems and symptoms of psychopathology.

  19. Single-photon emission computed tomography (SPECT)

    Time frame · Baseline and 26 weeks

    Registry description

    In this study we want to investigate whereas GLP-1 receptor stimulation induces changes in the striatal dopamine transporter availability in humans.

  20. fMRI (functional magnetic resonance imaging)

    Time frame · Baseline and 26 weeks

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2022

7 results

Exenatide once weekly for alcohol use disorder investigated in a randomized, placebo-controlled clinical trial.

Klausen et al. 2022JCI insightcited by 211

PMID 36066977PMC9675448DOI 10.1172/jci.insight.159863PUB-36066977

CC BY7 results

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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