Exenatide for Treating Cocaine Use Disorder

NCT04941521 | Completed Phase 1 Results DMC FDA Drug

• 1 other identifier: HSC-MS-21-0241
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect information about whether exenatide (Bydureon) may be safe and helpful as a medication treatment for individuals who want to stop using cocaine. 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.

Conditions

Cocaine Use Disorder

Keywords

Cocaine use; Exenatide; Cocaine treatment

Outcome Measures

Primary Outcomes (3)

• Feasibility as Assessed by Number of Participants Who Completed Treatment

  Treatment completion will be assessed by attendance at the end-of-treatment timepoint.

  Week 6

• Drug Safety as Assessed by Total Number of Adverse Events Reported During Treatment

  Adverse events (AEs) will be reported to study nurse during the course of treatment.

  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

  Urine drug screens were performed weekly. For a cocaine-negative urine drug screen result, benzoylecgonine levels must be under 300 ng/mL.

  From Week 1 to Week 6

Secondary Outcomes (10)

• Feasibility as Assessed by Number of Participants Enrolled

  Week 0

• Feasibility as Assessed by Number of Study Visits Attended

  From Week 1 to Week 6

• Feasibility as Assessed by Retention as Indicated by Total Number of Completed Study Visits

  From Week 1 to Week 6

• Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey

  Week 6

• Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week

  From Week 1 to Week 6

Study Arms (1)

Exenatide and Drug Counseling

EXPERIMENTAL

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

Drug: Exenatide 2 mg [Bydureon]; Behavioral: Drug Counseling

Interventions

Exenatide 2 mg [Bydureon] DRUG

Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.

Also known as: Bydureon

Exenatide and Drug Counseling

Drug Counseling BEHAVIORAL

Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.

Exenatide and Drug Counseling

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 in acceptable health on the basis of interview, medical history and physical exam.
• have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exception: pancreatic tests (lipase and amylase) must be within normal limits.
• consent to use an acceptable method of birth control during study participation and for one month after discontinuation of the study medication. Non-hormonal methods of contraception are recommended, including barrier contraceptives (e.g., diaphragm, cervical cap, male condom) or intrauterine device (IUD). Steroid contraceptives if used with non-hormonal methods are acceptable.
• 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.

You may not qualify if:

• current DSM-5 diagnosis for substance use disorder (of at least moderate severity) other than cocaine, marijuana, alcohol, or nicotine.
• current alcohol use that meets for physiological dependence requiring detoxification or makes participation medically unsafe as determined by the medical director.
• have a DSM-5 axis I psychiatric disorder, or anorexia nervosa, or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe (e.g., psychosis, dementia).
• significant current suicidal or homicidal ideation.
• Type 1 or type 2 diabetes mellitus (previously diagnosed or indicated by HbA1C level of ≥6.5%).
• have medical conditions contraindicating exenatide pharmacotherapy (e.g., personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, severe gastrointestinal disease (severe gastroparesis), previous history of pancreatitis or risk of pancreatitis, creatinine clearance \<45 or end stage renal disease, previous medically adverse reaction to exenatide or other GLP-1 receptor agonists).
• 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.
• impending incarceration.
• pregnant or nursing for female patients.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

UTHealth Behavioral and Biomedical Sciences Building

Houston, Texas, 77054, United States

Location

Related Publications (1)

• Yammine L, Balderas JC, Weaver MF, Schmitz JM. Feasibility of Exenatide, a GLP-1R Agonist, for Treating Cocaine Use Disorder: A Case Series Study. J Addict Med. 2023 Jul-Aug 01;17(4):481-484. doi: 10.1097/ADM.0000000000001147. Epub 2023 Feb 17.

  PMID: 37579116 DERIVED

MeSH Terms

Interventions

Exenatide

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Joy M Schmitz, PhD
• Organization: The University of Texas Health Science at Houston

Joy.M.Schmitz@uth.tmc.edu

713-486-2867

Study Officials

• Joy Schmitz, PhD

  UT Houston

  PRINCIPAL INVESTIGATOR

• Luba Yammine, PhD

  UT Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Faillace Chair, and Director for the Center for Neurobehavioral Research on Addiction

Model Details: Case series design run as a single-arm open-label pilot

Study Record Dates

• First Submitted: June 18, 2021
• First Posted: June 28, 2021
• Study Start: June 24, 2021
• Primary Completion: November 17, 2021
• Study Completion: November 17, 2021
• Last Updated: June 27, 2022
• Results First Posted: June 27, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)