GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration

What Was Tested

This registered phase 1 trial tested Exenatide.

The investigators plan to explore the effects of acute pre-treatment with the glucagon like peptide-1 (GLP-1) agonist, exenatide versus placebo, on the subjective (e.g., euphoric) and behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment seeking users of the drug.

It had four arms (groups): acute pre-treatment with exenatide (experimental), sub-chronic (5 day) treatment with exenatide (experimental), acute pre-treatment with placebo (placebo comparator) and sub-chronic (5 day) treatment with placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 13 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

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

Examples of who could join: Age 18 - 50 years,. Voluntary, written, informed consent,. Physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,. Recent street cocaine use in excess of amounts to be administered in the current study,. Intravenous and/or smoked (crack/ freebase) use,.

The full record lists 8 inclusion and 8 exclusion criteria; among the exclusions: other drug dependence (except nicotine) as determined by urine toxicology or interview; \< 1 year of cocaine dependence,; a primary major dsm-iv psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,.

How the Study Was Run

The set-up was randomized, parallel-group 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.

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

As a double-blind Exenatide 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 2014-11 with completion listed for 2018-08-01.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Mean cocaine inter-infusion interval (time frame: 3 hours).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Exenatide in 13 people.

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

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.