Exenatide for Treating Cocaine Use Disorder

What Was Tested

The trial (phase 1, phase 2) is built around Exenatide.

Although exenatide (Bydureon) is approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, it has not been approved by the FDA to treat cocaine use; therefore, it is called an investigational drug.

It had 1 arm (groups): Exenatide and Drug Counseling (experimental).

Participants will receive once weekly exenatide injections and drug counseling sessions.

The registry classes the interventions as behavioral and drug.

More on the Plan

Extended-release exenatide is a GLP-1 receptor agonist approved by the FDA for the treatment of type 2 diabetes.

The effect of extended-release exenatide on cocaine use in patients with a cocaine use disorder (CUD) has not yet been investigated.

A series of four case studies are being proposed to collect preliminary data on the feasibility, safety, and clinical effects of exenatide in treatment-seeking patients with CUD.

NIDA's current strategic plan prioritizes efforts to accelerate CUD medication development by rigorously testing novel molecular targets based on a translational research approach.

Who Took Part

The registry lists 3 actual participants took part.

It was open to people of any sex aged from 18 years up to 60 years.

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

Examples of who could join: Between 18 and 60 years of age. Meet DSM-5 criteria for current cocaine use disorder as measured by the Structured Clinical Interview for DSM-5 (SCID). Have at least 1 cocaine-positive urine specimen (≥ 150 ng/mL) during intake. Be able to understand the consent form and provide written informed consent. Be able to provide the names of at least 2 persons who can generally locate their whereabouts.

The full record lists 8 inclusion and 10 exclusion criteria; among the exclusions: current dsm-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, alcohol, or nicotine; taking medications that could adversely interact with exenatide (e.g., oral or injectable blood glucose lowering medications); having conditions of probation or parole requiring reports of drug use to officers of the court.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2021-06-24 with completion listed for 2021-11-17.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Feasibility as Assessed by Number of Participants Who Completed Treatment (time frame: Week 6). Drug Safety as Assessed by Total Number of Adverse Events Reported During Treatment (time frame: From Week 1 to Week 6). Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results (time frame: From Week 1 to Week 6).

It also tracked 10 secondary outcomes, for example Feasibility as Assessed by Number of Participants Enrolled, Feasibility as Assessed by Number of Study Visits Attended, Feasibility as Assessed by Retention as Indicated by Total Number of Completed Study Visits and Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2 trial of Exenatide in 3 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 Exenatide compound page, all human trials.