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WithdrawnPhase 1

Exenatide For Reducing the Reinforcing Effects of Cocaine

A Human Laboratory Study of Exenatide for Reducing the Reinforcing Effects of Cocaine

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

actual

Study population

Alcohol / substance use

Key I/E criterion

Primary endpoints

Alcohol consumption, changeSubjective Effects

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 IDNCT06252623
Org study IDH-52307

Timeline

Milestones

Study first posted2024-02-12actual
Study start2024-08-01actual
Primary completion2026-03-01estimated
Last update posted2026-03-13actual
Study completion2026-12-31estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. English-speaking

2. Male or female ≥ 18 and ≤ 65 years of age

3. Willing and able to provide written informed consent and participate in all required study activities

4. Self-reported recent use of smoked or IV COC verified by a COC positive urine (≥ 150 ng/mL)

5. Report using COC for ≥ 10 years and using ≥ 2 grams of COC/week

6. Have vital signs as follows, resting pulse between 50 and 95 bpm, blood pressure (BP) between 90-150 mmHg systolic and 45-95 mmHg diastolic.

7. 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

8. Have a medical history, physical examination, electrocardiogram (ECG), drug-use history, and the Mini-International Neuropsychiatric Interview (M.I.N.I.) demonstrating no clinically significant contraindications for study participation, in the judgment of a Study Physician and the Principal Investigator.

9. Agree (if the subject is female and of child-bearing potential) to use at least one of the following methods of birth control from time of the first administration of the study drug to at least 7 days post the last dose of study drug, unless the partner is surgically sterile (underwent vasectomy),

1. oral contraceptives,

2. contraceptive sponge,

3. patch,

4. double barrier (diaphragm/spermicidal or condom/spermicidal),

5. intrauterine contraceptive system,

6. etonogestrel implant,

7. medroxyprogesterone acetate contraceptive injection,

8. complete abstinence from sexual intercourse, and/or

9. hormonal vaginal contraceptive ring

10. Women of child-bearing potential must provide negative urine pregnancy tests prior to randomization, and at study visits as indicated in the Research Strategy

11. No contraindications/allergies to COC or exenatide

12. Cardiovascular and subjective responses to COC within acceptable

Exclusion criteria

1. Clinically significant medical conditions .

2. Meet diagnostic criteria for substance-use disorders other than for CUD that in the opinion of the study physician would comprise the well-being of the participant.

3. Seeking treatment for a substance use disorder.

4. Any laboratory test deemed clinically significant by the study physician.

5. Type 1 or type 2 Diabetes Mellitus (HbA1C level of ≥6.5%)

6. Previous medically adverse reaction to the study medications (Bydureon) or COC.

7. Medication use that might interact with COC or exenatide, or otherwise compromise safety.

8. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

9. Severe cardiovascular disease (history of myocardial infarction, life-threatening arrhythmia, or worsening angina pectoris).

10. Severe gastrointestinal disease (i.e., severe gastroparesis).

11. Previous history of pancreatitis or risk of pancreatitis.

12. Creatinine clearance <45 or end stage renal disease (ESRD).

13. Contraindications to treatment with exenatide (e.g., personal of family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type-2; history of pancreatitis or risk of pancreatitis).

14. Participation in a clinical trial within 30 days of admission.

15. Positive urine pregnancy test or females trying to conceive, donated ova, are pregnant, or are lactating or breast feeding at screening or throughout study.

16. Positive urine screen for drugs-of-abuse, other than COC or marijuana, or breath alcohol test. Note, if positive for opioids or oxycodone but recent opioid use for acute pain is reported by the subject, then the subject can be included at the discretion of the Primary Investigator and/or Study Physician.

17. Have a history of suicidal ideation.

18. Have any illness or condition which in the opinion of the Principal Investigator and/or the Study Physician would preclude safe and/or successful completion of the study.

Endpoints (3)

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

Patient-reported / QoL
1
Safety / tolerability / PK
1
Other clinical outcomes
1

Patient-reported / QoL

1 endpoint
Primary/protocol endpoint

Subjective Effects

Time frame:6 weeks

descriptive

Safety / tolerability / PK

1 endpoint
Other/protocol endpoint

Incidence of Treatment-Emergent Adverse Events (TEAEs)

Time frame:6 weeks

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

1 endpoint
Primary/protocol endpoint/low confidence

Proportion of up to 10 active cocaine doses

Time frame:6 weeks

Alcohol consumption, change

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.