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

Description

The investigators plan to explore the effects of acute pre-treatment with the glucagon like peptide-1 (GLP-1) agonist, exenatide versus placebo, on the subjective (e.g., euphoric) and behavioral effects (e.g., self-administration) of cocaine in experienced, non-treatment seeking users of the drug. Additionally, the investigators plan to explore the effects of sub-chronic (5-day) treatment with exenatide as compared to placebo on the subjective (e.g., euphoric) and behavioral (self-administration) effects of cocaine in experienced, non-treatment seeking users of the drug.

Study Start Date

November 2014

Estimated Completion Date

November 2019

Interventions

  • Drug: exenatide
  • Drug: placebo
  • Drug: cocaine hydrochloride

Specialties

  • Family Medicine: Substance Abuse
  • Nurse Practitioner: Substance Abuse

MeSH Terms

  • Cocaine Dependence
  • exenatide

Study ID

Yale University -- 1409014655

Status

Unknown

Trial ID

NCT02302976

Study Type

Interventional

Trial Phase

Phase 1

Enrollment Quota

24

Sponsor

Yale University

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 (?-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 (?-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.

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Connecticut Mental Health Center - New Haven, Connecticut 17.3 miles Edward Gaiser BA 203-974-7559 edward.gaiser@yale.edu

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