Phase 2
N=3
Exenatide for Treating Cocaine Use Disorder
Cocaine Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04941521 ↗Enrolled (actual)
3
Serious AEs
33.3%
Results posted
Jun 2022
Primary outcome: Primary: Feasibility as Assessed by Number of Participants Who Completed Treatment — 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Exenatide 2 mg [Bydureon] (Drug); Drug Counseling (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility as Assessed by Number of Participants Who Completed Treatment |
3 | — |
| PRIMARY Drug Safety as Assessed by Total Number of Adverse Events Reported During Treatment |
7 | — |
| PRIMARY Clinical Effect of Exenatide as Assessed by Cocaine Use During Treatment as Indicated by Number of Participants With Cocaine-positive Urine Drug Screen Results |
3; 3; 3; 2; 2; 2 | — |
| SECONDARY Feasibility as Assessed by Number of Participants Enrolled |
3 | — |
| SECONDARY Feasibility as Assessed by Number of Study Visits Attended |
6 | — |
| SECONDARY Feasibility as Assessed by Retention as Indicated by Total Number of Completed Study Visits |
6 | — |
| SECONDARY Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey |
7.66; 6.00; 7.33; 7.33 | — |
| SECONDARY Clinical Effect of Exenatide as Assessed by Number of Participants Who Self-reported Cocaine Use on 50% or More Days of the Week |
2; 2; 1; 2; 1; 2 | — |
| SECONDARY Clinical Effect of Exenatide as Indicated by Number of Participants Who Reported a Reduction in Craving by Week 6 as Indicated by Cocaine Craving on the Brief Substance Craving Scale |
2 | — |
| SECONDARY Clinical Effect of Exenatide as Assessed by Number of Participants Who Had a Decrease in Drug Demand by Week 6 |
1 | — |
| SECONDARY Clinical Effect of Exenatide as Assessed by Number of Participants Who Were Below the Clinical Range for Depression by Week 6 as Indicated by the Beck Depression Inventory |
3 | — |
| SECONDARY Clinical Effect of Exenatide as Indicated by Number of Participants Who Had an Increase in Positive Affect Symptoms by Week 6 as Indicated on the Positive/Negative Affect Schedule |
1 | — |
| SECONDARY Clinical Effect of Exenatide as Indicated by Number of Participants Who Had a Decrease in Negative Affect Symptoms Indicated on the Positive/Negative Affect Schedule |
1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04941521). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.