Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers

What Was Tested

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

Background: \- Ghrelin is a hormone in the human body that is mostly produced by the stomach.

It had four arms (groups): ASA/Ghrelin (experimental), ASA/Placebo (placebo comparator), fMRI/Ghrelin (experimental) and fMRI/Placebo (placebo comparator).

The registry classes the interventions as drug and procedure.

More on the Plan

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

In addition to the ARC, GHS receptors (GHS-Rs) are also highly expressed in the caudal brain stem, the ventral tegmental area (VTA), hippocampus, substantia nigra, and dorsal and medial raphe nuclei.

This supports the hypothesis that ghrelin is involved in mediating the rewarding properties of ethanol.

The researchers will also assess a number of secondary aims.

Who Took Part

17 actual participants took part.

It was open to people of any sex aged from 21 years up to 60 years.

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

The full record lists 1 inclusion and 0 exclusion criteria.

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

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

Each person switched between Ghrelin and the comparison at some point, usually with a gap in between.

As a double-blind Ghrelin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-12-13 with completion listed for 2017-06-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Ghrelin in 17 people.

Its size is small, so on its own it can only give an early look.

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.