Effects of Ghrelin on Alcohol Cue Reactivity and Craving

What Was Tested

The trial (not phased) is built around Ghrelin.

Accordingly, identifying new potential neuropharmacological targets in the treatment of alcohol dependence represents a high priority in public health.

Ghrelin is a 28-amino acid peptide acting as the endogenous ligand for the growth hormone secretagogue receptor (GHS-R).

It had three arms (groups): one (active comparator), one (active comparator) and Saline Solution (placebo comparator).

Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 45 actual participants took part.

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

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Understanding that this is not a treatment study. Breath alcohol concentration (BAC) equal to 0.00 when the participants sign the informed consent document. Age between 18 and 70 years old (inclusive). Diagnosis of Alcohol dependence using Module E of the structured clinical interview for the Diagnostic and Statistical Manual of Mental Disorders - Text Revised (DSM-IV-TR). Good health as confirmed by medical history, physical examination, electrocardiogram (ECG), laboratory tests and vital signs.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: individuals expressing interest in treatment for alcoholism; current (last 12 months) diagnosis of dependence on any psychoactive substance other than alcohol and nicotine (according to the dsm-iv-tr); history of hospitalization for alcohol intoxication delirium, alcohol withdrawal delirium or seizure.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Ghrelin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

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

It started in 2011-04 with completion listed for 2012-11.

It ran at 1 site in United States.

What Was Measured

The main thing measured (primary outcome): Alcohol Visual Analogue Scale (A-VAS) (time frame: approximately 30 minutes after drug administration). Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability (time frame: participants will be followed after the cue-reactivity experiment, an expected average of 7 days). Salivation (time frame: approximately 30 minutes after drug administration).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Ghrelin in 45 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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