Impact of a Non-Drug Choice on Cocaine Reinforcement

NCT ID: NCT01906346

Last Updated: 2019-05-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.

Detailed Description

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Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Low Value Alternative Reinforcer

A low value reinforcer will be made available as an alternative to cocaine and placebo.

Group Type EXPERIMENTAL

Cocaine

Intervention Type DRUG

Three active doses of cocaine will be made available for self-administration during experimental sessions.

Placebo

Intervention Type DRUG

Placebo cocaine will be made available for self-administration during experimental sessions.

Medium Value Reinforcer

A medium value reinforcer will be made available as an alternative to cocaine and placebo.

Group Type EXPERIMENTAL

Cocaine

Intervention Type DRUG

Three active doses of cocaine will be made available for self-administration during experimental sessions.

Placebo

Intervention Type DRUG

Placebo cocaine will be made available for self-administration during experimental sessions.

High Value Reinforcer

A high value reinforcer will be made available as an alternative to cocaine and placebo.

Group Type EXPERIMENTAL

Cocaine

Intervention Type DRUG

Three active doses of cocaine will be made available for self-administration during experimental sessions.

Placebo

Intervention Type DRUG

Placebo cocaine will be made available for self-administration during experimental sessions.

Interventions

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Cocaine

Three active doses of cocaine will be made available for self-administration during experimental sessions.

Intervention Type DRUG

Placebo

Placebo cocaine will be made available for self-administration during experimental sessions.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cocaine dependence, otherwise healthy

Exclusion Criteria

* Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Joshua A. Lile, Ph.D.

OTHER

Sponsor Role lead

Responsible Party

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Joshua A. Lile, Ph.D.

Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Joshua A Lile, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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Laboratory of Human Behavioral Pharmacology

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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R01DA033364-01

Identifier Type: NIH

Identifier Source: org_study_id

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