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

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

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.

It had two arms (groups): one (active comparator) and BD PosiFlush (saline) (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Number of patients and target population: 144 patients with a diagnosis of alcohol dependence and 25 healthy participants (described later).

The medication will be provided as a supplement to a standard, psychosocial alcohol treatment program.

All patients will receive psychosocial alcohol treatment based on psycho educative elements, motivational interviewing and cognitive behavioural treatment.

Skilled staff members administer the treatment.

Who Took Part

152 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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.

The full record lists 5 inclusion and 22 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2017-08-07 with completion listed for 2020-03-15.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Heavy drinking days (time frame: 30 days prior to baseline and 30 days prior to final follow up at 26 weeks).

It also tracked 20 secondary outcomes, for example Total alcohol consumption, Penn Alcohol Craving Scale (PACS) score, Alcohol Use Disorders Identification Test (AUDIT) score, Drug Use Disorders Identification Test (DUDIT) score, Screen For Cognitive Impairment in Psychiatry (SCIP) test and Plasma-gamma-glutamyltransferase (GGT).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 152 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.