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Exenatide for Cocaine Use Disorder

Phase 1
Recruiting
Led By Christopher D Verrico, PhD
Research Sponsored by Christopher Verrico
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No contraindications/allergies to COC or exenatide
Male or female aged 18 to 65
Must not have
Creatinine clearance <45 or end stage renal disease (ESRD)
History of suicidal ideation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks

Summary

"This trial will test the safety and effectiveness of a drug called exenatide (Bydureon) in treating cocaine addiction. The study will involve monitoring how individuals respond to cocaine while taking either

Who is the study for?
This trial is for individuals with Cocaine Use Disorder. Participants must meet certain health requirements, but specific inclusion criteria are not listed. People who have conditions that could interfere with the study or pose a risk to their safety based on other medications or health issues may be excluded.
What is being tested?
The trial is testing Exenatide (Bydureon), which is normally used for type 2 diabetes, to see if it can help people with Cocaine Use Disorder by reducing cocaine's effects and desire for use. It compares Exenatide against a placebo in an inpatient setting where participants' reactions to cocaine are monitored.
What are the potential side effects?
While the side effects of Exenatide in this context aren't detailed here, common ones from its use in diabetes include nausea, vomiting, diarrhea, dizziness, headache and potential injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am not allergic to COC or exenatide.
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I am between 18 and 65 years old.
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I have been using cannabis for over 10 years, at least 2 grams per week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidney function is very low or I have end-stage kidney disease.
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I have thought about suicide in the past.
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I have diabetes with an HbA1C level of 6.5% or higher.
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I do not have severe heart, stomach issues, or a history/risk of pancreatitis.
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I cannot take exenatide due to health reasons.
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I or my family have a history of thyroid cancer or MEN2.
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I am not pregnant, trying to conceive, donating eggs, or breastfeeding.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of up to 10 active cocaine doses
Subjective Effects
Other study objectives
Incidence of Treatment-Emergent Adverse Events (TEAEs)

Side effects data

From 2017 Phase 4 trial • 8 Patients • NCT02058940
38%
Death
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exenatide

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug: Exenatide 2 mg [Bydureon]Experimental Treatment1 Intervention
Participants will receive once-weekly subcutaneous exenatide (2 mg) injections for 6 weeks.
Group II: Drug: PlaceboPlacebo Group1 Intervention
Participants will receive once-weekly subcutaneous saline (i.e., placebo) injections for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exenatide
2010
Completed Phase 4
~2970

Find a Location

Who is running the clinical trial?

Christopher VerricoLead Sponsor
Christopher D. VerricoLead Sponsor
1 Previous Clinical Trials
75 Total Patients Enrolled
Christopher D Verrico, PhDPrincipal InvestigatorBaylor College of Medicine
~29 spots leftby Mar 2026
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