← Trials/Trial dossier/NCT02302976

CompletedPhase 1

GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration

Lead sponsor

Yale University

Asset

Exenatide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

13

actual

Study population

Alcohol / substance use

Key I/E criterion

Primary endpoint

Mean cocaine inter-infusion interval

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 IDNCT02302976
Org study ID1409014655
Secondary ID1R21DA040914-01A1

Timeline

Milestones

Study first posted2014-11-27estimated
Primary completion2018-08-01actual
Study completion2018-08-01actual
Last update posted2023-02-16actual
Study start2014-11 (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Alcohol / substance use

Eligibility

Who can enroll

Minimum age18 Years
Maximum age50 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. age 18 - 50 years,

2. voluntary, written, informed consent,

3. physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,

4. DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)

5. recent street cocaine use in excess of amounts to be administered in the current study,

6. intravenous and/or smoked (crack/ freebase) use,

7. positive urine toxicology screen for cocaine,

8. for females, non-lactating, no longer of child-bearing potential (or agree to practice effective contraception during the study), and a negative serum pregnancy (β-HCG) test.

Exclusion criteria

1. Other drug dependence (except nicotine) as determined by urine toxicology or interview

2. < 1 year of cocaine dependence,

3. a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,

4. a history of significant medical (cardiovascular) or neurological illness, ie prior myocardial infarction, current active symptoms of cardiovascular disease / angina, evidence of cocaine-related cardiovascular symptoms, prior arrhythmias or need for cardiovascular resuscitation, neurovascular events such as transient ischemic attacks, stroke, and/or seizures Parameters re: elevations in vital signs are now explicitly specified under "Safety features built into our one-day self-administration paradigm).

5. current use of psychotropic and/or potentially psychoactive prescription medication,

6. seeking treatment for drug abuse/dependence (for experimental cocaine component),

7. physical or laboratory (β-HCG) evidence of pregnancy.

8. current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

Endpoints (1)

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.

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

Mean cocaine inter-infusion interval

Time frame:3 hours

descriptive, improvement

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.