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Trial · Interventional

CompletedPhase 1/2Results postedRegistry data

Exenatide for Treating Cocaine Use Disorder

NCTNCT04941521 (opens ClinicalTrials.gov in a new tab)Other idHSC-MS-21-0241
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1/2
Enrollment
3 participants (actual)
Sponsor
The University of Texas Health Science Center, Houston · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
24 Jun 2021
Primary completion
17 Nov 2021
Completion
17 Nov 2021
First posted
28 Jun 2021
Last update posted
27 Jun 2022
Conditions
Cocaine Use Disorder

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022
  1. Ph 1/2

    Exenatide for Treating Cocaine Use Disorder

    NCT04941521

    24 Jun 2021 to 17 Nov 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Exenatide 2 mg [Bydureon]Drug
  • Drug CounselingBehavioral

Arms1

  • Experimental

    Exenatide and Drug Counseling

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

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Feasibility as Assessed by Number of Participants Who Completed Treatment

    Time frame · Week 6

    Registry description

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

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

    Time frame · From Week 1 to Week 6

    Registry description

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

  3. 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

    Registry description

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

Secondary outcomes(10)

  1. Feasibility as Assessed by Number of Participants Enrolled

    Time frame · Week 0

    Registry description

    Enrollment will be assessed by the number of participants signing the informed consent.

  2. Feasibility as Assessed by Number of Study Visits Attended

    Time frame · From Week 1 to Week 6

    Registry description

    There were 6 study visits planned.

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

    Time frame · From Week 1 to Week 6

    Registry description

    Retention will be assessed by the total number of completed study visits. A completed study visit is a visit in which the participant attended and received the study treatment.

  4. Feasibility as Indicated by Overall Acceptability as Reported on the Satisfaction Survey

    Time frame · Week 6

    Registry description

    The Satisfaction Survey includes a 9-point likert scale that ranges from 1 to 9, with a higher score indicating greater acceptability.

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

    Time frame · From Week 1 to Week 6

    Registry description

    Timeline Followback (TLFB) administered once weekly.

  6. 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

    Time frame · From Week 0 to Week 6

    Registry description

    The brief substance craving scale (BSCS) is a 16-item, self-report instrument that assesses craving for cocaine and other substances of abuse over a 24 hour period. The domains of intensity, frequency, and duration are recorded on a five-point Likert scale. The range of scores for each domain is 0 to 4, and the total score is the sum of all three domains. The total score range is 0 to 12, and higher scores indicate higher craving (worse outcome.)

  7. Clinical Effect of Exenatide as Assessed by Number of Participants Who Had a Decrease in Drug Demand by Week 6

    Time frame · From Week 0 to Week 6

    Registry description

    Drug demand will be measured by the computerized Cocaine Purchasing Task (CPT). The CPT asks participants how much cocaine they would purchase at the beginning of a hypothetical day as the cost of cocaine increases from $0 to $1,000. The CPT simulates changes in price and consumption of drug in order to assess demand curves associated with drug consumption. The CPT will assess both cocaine reward value as well as motivation to consume cocaine.

  8. 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

    Time frame · Week 6

    Registry description

    The Beck Depression Inventory score ranges from 0 to 63, with a higher score indicating greater depressive symptoms. The scores from each timepoint will be plotted as a trend line.

  9. 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

    Time frame · From Week 0 to Week 6

    Registry description

    The Positive/Negative Affect Schedule is a 20-item questionnaire divided into 10 positive affect items and 10 negative affect items. The score for the positive affect items ranges from 10 to 50, with a higher score indicating higher levels of positive affect. The scores from each timepoint will be plotted as a trend line.

  10. 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

    Time frame · From Week 0 to Week 6

    Registry description

    The Positive/Negative Affect Schedule is a 20-item questionnaire divided into 10 positive affect items and 10 negative affect items. The score for the negative affect items ranges from 10 to 50, with a lower score indicating lower levels of negative affect. The scores from each timepoint will be plotted as a trend line.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Week 6

Feasibility as Assessed by Number of Participants Who Completed Treatment

GroupValue (Participants)
Exenatide and Drug Counseling3
Primary outcomeNumber· From Week 1 to Week 6

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

GroupValue (adverse events)
Exenatide and Drug Counseling7
Primary outcomeCount of participants· 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

GroupValue (Participants)
Exenatide and Drug Counseling3
Secondary and other outcome results(5)
Secondary outcomeCount of participants· Week 0

Feasibility as Assessed by Number of Participants Enrolled

GroupValue (Participants)
Exenatide and Drug Counseling3
Secondary outcomeMean· From Week 1 to Week 6

Feasibility as Assessed by Number of Study Visits Attended

GroupValue (study visits)Spread
Exenatide and Drug Counseling60
Secondary outcomeMean· From Week 1 to Week 6

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

GroupValue (completed study visits)Spread
Exenatide and Drug Counseling60
Secondary outcomeMean· Week 6

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

GroupValue (score on a scale)Spread
Exenatide and Drug Counseling7.661.52
Secondary outcomeCount of participants· From Week 1 to 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

GroupValue (Participants)
Exenatide and Drug Counseling2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide and Drug CounselingParticipants will receive once weekly exenatide injections and drug counseling sessions. Exenatide 2 mg \[Bydureon\]: 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. Drug Counseling: Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.0 / 31 / 32 / 3

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

PubMed tag: none · 2023

4 results

Feasibility of Exenatide, a GLP-1R Agonist, for Treating Cocaine Use Disorder: A Case Series Study.

Yammine et al. 2023Journal of addiction medicinecited by 20

PMID 37579116DOI 10.1097/adm.0000000000001147PUB-37579116

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 60 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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