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



Status:Recruiting
Conditions:Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 50
Updated:1/11/2018
Start Date:November 2014
End Date:November 2019
Contact:Jessica Costeines, MA
Email:jessica.costeines@yale.edu
Phone:203-974-7559

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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.


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.
We found this trial at
1
site
New Haven, Connecticut 06508
Principal Investigator: Robert T Malison, MD
Phone: 203-974-7559
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mi
from
New Haven, CT
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