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

NCT ID: NCT02302976

Last Updated: 2023-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2018-08-01

Brief 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.

Conditions

Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

acute pre-treatment with exenatide

This arm plans to explore the effects of acute pre-treatment with the glucagon like peptide-1 (GLP-1) agonist, exenatide vs. 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. We propose to study 24 subjects in a within-subject (two-day, randomized, placebo-controlled) human laboratory study of self-regulated cocaine administration. We hypothesize that acute treatment with exenatide will reduce cocaine-induced euphoria and self-regulated cocaine administration as compared to placebo

Group Type: EXPERIMENTAL

cocaine hydrochloride

Intervention Type: DRUG

exenatide

Intervention Type: DRUG

sub-chronic (5 day) treatment with exenatide

This arm plans 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. Upon completion of arm 1, subjects may opt to be randomized to five days of treatment with either exenatide or placebo, followed by a one-day human laboratory study of self-regulated cocaine administration. We hypothesize that subjects treated with exenatide (up to N=12) will demonstrate decreased self-regulated cocaine administration as compared to subjects treated with placebo (up to N=12).

Group Type: EXPERIMENTAL

cocaine hydrochloride

Intervention Type: DRUG

exenatide

Intervention Type: DRUG

acute pre-treatment with placebo

This arm plans to explore the effects of acute pre-treatment with the glucagon like peptide-1 (GLP-1) agonist, exenatide vs. 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. We propose to study 24 subjects in a within-subject (two-day, randomized, placebo-controlled) human laboratory study of self-regulated cocaine administration. We hypothesize that acute treatment with exenatide will reduce cocaine-induced euphoria and self-regulated cocaine administration as compared to placebo

Group Type: PLACEBO_COMPARATOR

cocaine hydrochloride

Intervention Type: DRUG

placebo

Intervention Type: DRUG

sub-chronic (5 day) treatment with placebo

This arm plans 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. Upon completion of arm 1, subjects may opt to be randomized to five days of treatment with either exenatide or placebo, followed by a one-day human laboratory study of self-regulated cocaine administration. We hypothesize that subjects treated with exenatide (up to N=12) will demonstrate decreased self-regulated cocaine administration as compared to subjects treated with placebo (up to N=12).

Group Type: PLACEBO_COMPARATOR

cocaine hydrochloride

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Interventions

cocaine hydrochloride

Intervention Type: DRUG

exenatide

Intervention Type: DRUG

placebo

Intervention Type: DRUG

Other Intervention Names

byetta

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Gustavo Angarita

Assistant Professor of Clinical Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gustavo Angarita, M.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Connecticut Mental Health Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

1R21DA040914-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1409014655

Identifier Type: -

Identifier Source: org_study_id