GLP-1 Agonism for Blocking Cocaine Euphoria and Self-Administration
Completed · Phase 1 · Has a placebo group
Conditions studied: Cocaine Dependence
In brief
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.
Key facts
- Study ID
- NCT02302976
- Run by
- Yale University
- People needed
- 13
- Starts
- 2014-11-01
- Expected to finish
- 2018-08-01
- Last updated by the study team
- 2023-02-16
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Connecticut Mental Health Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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