The Effects of Exenatide, a GLP-1 Agonist, on Alcohol Self-Administration in Heavy Drinkers

What Was Tested

This registered phase 1 trial tested Exenatide.

It had two arms (groups): Exenatide then Placebo (experimental) and Placebo then Exenatide (experimental).

The registry classes the interventions as drug and other.

Who Took Part

Enrollment: 8 actual participants took part.

It was open to people of any sex aged from 21 years up to 55 years.

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

Examples of who could join: 21-55 years of age. Able to verify age with a state or federal picture identification. Reports at least one episode of binge drinking (\>3 SDUs for women, \>4 SDUs for men) an average of once per week in the four weeks prior to baseline screening.

The full record lists 5 inclusion and 27 exclusion criteria; among the exclusions: if female, pregnant, nursing, have plans to become pregnant; if female, does not agree to use an accepted form of birth control; current risk of suicidality (mini suicidality score greater than 8 (low risk) or yes to the ideation question #4 of the c-ssrs).

How the Study Was Run

Design: randomized, crossover and quadruple-blind.

Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the participants nor the staff measuring them knew who was on Exenatide, so expectations could not easily colour the readings.

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

It started in 2019-05-02 with completion listed for 2021-07-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 8 people.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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