GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT04941521

CompletedPhase 1, PHASE2Results posted

Exenatide for Treating Cocaine Use Disorder

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

Lead sponsor

The University of Texas Health Science Center, Houston

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Alcohol / substance use

Key I/E criterion

—

Primary endpoints

•Feasibility•Drug Safety•Clinical Effect of Exenatide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04941521

Org study IDHSC-MS-21-0241

Timeline

Milestones

Study start2021-06-24actual

Study first posted2021-06-28actual

Primary completion2021-11-17actual

Study completion2021-11-17actual

Last update posted2022-06-27actual

Results first posted2022-06-27actual

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years

Maximum age60 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (26)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Patient-reported / QoL

4 endpoints

Secondary/registry result

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

Time frame:Week 6

descriptive

Posted result

Group	Value (mean), score on a scale	95% CI
Exenatide and Drug Counselingtreatment helpfulness	7.66	—
treatment usefulness	6.00	—
likelihood of treatment recommendation	7.33	—
desire to continue treatment	7.33	—

Secondary/protocol endpoint

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

Time frame:Week 6

descriptive

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Safety / tolerability / PK

4 endpoints

Primary/registry result

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

Time frame:From Week 1 to Week 6

event count, event

Posted result

Group	Value (number), adverse events	95% CI
Exenatide and Drug Counseling	7	—

Primary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counselingweek 1	3	—
week 2	3	—
week 3	3	—
week 4	2	—
week 5	2	—
week 6	2	—

Primary/protocol endpoint

Feasibility as Assessed by Number of Participants Who Completed Treatment

Time frame:Week 6

threshold achievement, descriptive

Primary/protocol endpoint

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

Time frame:From Week 1 to Week 6

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

15 endpoints

Primary/registry result

Feasibility as Assessed by Number of Participants Who Completed Treatment

Time frame:Week 6

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	3	—

Primary/protocol endpoint/low confidence

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

AUDIT score

threshold achievement, improvement

Secondary/registry result

Feasibility as Assessed by Number of Participants Enrolled

Time frame:Week 0

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	3	—

Secondary/registry result

Feasibility as Assessed by Number of Study Visits Attended

Time frame:From Week 1 to Week 6

event count, event

Posted result

Group	Value (mean), study visits	95% CI
Exenatide and Drug Counseling	6	—

Secondary/registry result

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

Time frame:From Week 1 to Week 6

event count, event

Posted result

Group	Value (mean), completed study visits	95% CI
Exenatide and Drug Counseling	6	—

Secondary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counselingweek 1	2	—
week 2	2	—
week 3	1	—
week 4	2	—
week 5	1	—
week 6	2	—

Secondary/registry result

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

change from baseline, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	2	—

Secondary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	1	—

Secondary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	3	—

Secondary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	1	—

Secondary/registry result

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

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Exenatide and Drug Counseling	1	—

Secondary/protocol endpoint/low confidence

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

AUDIT score

threshold achievement, improvement

Secondary/protocol endpoint/low confidence

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

AUDIT score

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Secondary/protocol endpoint

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

threshold achievement, improvement

Other (unclassified)

3 endpoints

Secondary/protocol endpoint/low confidence

Feasibility as Assessed by Number of Participants Enrolled

Time frame:Week 0

descriptive

Secondary/protocol endpoint/low confidence

Feasibility as Assessed by Number of Study Visits Attended

Time frame:From Week 1 to Week 6

descriptive

Secondary/protocol endpoint

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

Time frame:From Week 1 to Week 6

event count, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Feasibility of Exenatide, a GLP-1R Agonist, for Treating Cocaine Use Disorder: A Case Series Study.
Journal of addiction medicine2023 Jul-Aug 01 (year)PMID37579116doi:10.1097/ADM.0000000000001147via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.