GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration (NCT02302976) | Clinical Trial Compass
CompletedPhase 1
GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration
United States13 participantsStarted 2014-11
Plain-language summary
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.
Who can participate
Age range18 Years – 50 Years
SexALL
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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,
✓. 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).