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Drug: Exenatide 2 mg [Bydureon] for Cocaine Use Disorder

Phase 1

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of up to 10 active cocaine doses

Subjective Effects

Other outcome measures

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%

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Christopher VerricoLead Sponsor

Christopher D. VerricoLead Sponsor

Christopher D Verrico, PhDPrincipal InvestigatorBaylor College of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities for patients to participate in this clinical trial at the moment?

"Following a review of the data on clinicaltrials.gov, it is apparent that recruitment for this specific trial has ceased. The initial posting date was March 1st, 2024, with the latest update recorded on February 7th, 2024. Despite this trial no longer accepting candidates, there are currently 27 alternative trials actively seeking participants."

Answered by AI

Is there an age cutoff for participants in this clinical study, specifically regarding individuals under 35 years of age?

"This investigation is open to individuals over 18 years old and under 65 years of age."

Answered by AI

Has the medication Exenatide 2 mg [Bydureon] received approval from the FDA?

"Based on the current Phase 1 trial status, our team rates Drug: Exenatide 2 mg [Bydureon] with a safety score of 1 due to the scarcity of data supporting both its safety and efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Exenatide For Reducing the Reinforcing Effects of Cocaine

Christopher D. Verrico 2024. "Exenatide For Reducing the Reinforcing Effects of Cocaine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06252623.

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