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NCT02302976·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

13

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

cocaine hydrochloride

DRUG

exenatide

DRUG

placebo

Timeline

From registration to results.

  1. First posted

    Nov 27, 2014

  2. Study start

    Nov 2014

  3. Primary completion

    Aug 1, 2018

  4. Study completion

    Aug 1, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Feb 16, 2023

Outcomes

What the study measures.

Primary outcomes

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.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
50 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Connecticut Mental Health Center

New Haven, Connecticut, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.