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Completed

NCT Number: NCT02302976

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 - 50 years,
  • voluntary, written, informed consent,
  • physically healthy by medical history, physical, neurological, ECG, and laboratory examinations,
  • DSM-IV criteria for Cocaine Abuse (305.60) or Cocaine Dependence (304.20)
  • recent street cocaine use in excess of amounts to be administered in the current study,
  • intravenous and/or smoked (crack/ freebase) use,
  • positive urine toxicology screen for cocaine,
  • 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

  • Other drug dependence (except nicotine) as determined by urine toxicology or interview
  • < 1 year of cocaine dependence,
  • a primary major DSM-IV psychiatric diagnosis (schizophrenia, bipolar disorder, etc.), unrelated to cocaine,
  • 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).
  • current use of psychotropic and/or potentially psychoactive prescription medication,
  • seeking treatment for drug abuse/dependence (for experimental cocaine component),
  • physical or laboratory (β-HCG) evidence of pregnancy.
  • current use of any medication (prescription or over-the-counter) determined to cause potential drug interactions by the study physicians.

Treatment and study plan

cocaine hydrochloride

Drug

exenatide

Drug

Other names: byetta

Placebo

Drug

Primary outcomes

  1. Mean cocaine inter-infusion interval

    Time frame: 3 hours

    Subjects will complete a 90 minute long "binge" cocaine self administration session (16mg/70kg). Mean inter-infusion intervals (time between cocaine boluses) will then be averaged by adding all intervals within the session and dividing by 90. Intervals during which pump access is withheld (due to increase in vital signs) will be excluded. Data on cocaine self-administration (total number of responses, infusions, and III), subjective effects, and vital signs will be checked for normality prior to analysis using Kolmogorov-Smirnov statistics and normal probability plots. The significance level for all statistical tests will be set at p<.05.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 27, 2014
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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