Impact of a Non-Drug Choice on Cocaine Reinforcement

April 19, 2019 updated by: Joshua A. Lile, Ph.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0086
        • Laboratory of Human Behavioral Pharmacology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Cocaine dependence, otherwise healthy

Exclusion Criteria:

  • Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Low Value Alternative Reinforcer
A low value reinforcer will be made available as an alternative to cocaine and placebo.
Drug: Cocaine
Three active doses of cocaine will be made available for self-administration during experimental sessions.
Drug: Placebo
Placebo cocaine will be made available for self-administration during experimental sessions.
Experimental: Medium Value Reinforcer
A medium value reinforcer will be made available as an alternative to cocaine and placebo.
Drug: Cocaine
Three active doses of cocaine will be made available for self-administration during experimental sessions.
Drug: Placebo
Placebo cocaine will be made available for self-administration during experimental sessions.
Experimental: High Value Reinforcer
A high value reinforcer will be made available as an alternative to cocaine and placebo.
Drug: Cocaine
Three active doses of cocaine will be made available for self-administration during experimental sessions.
Drug: Placebo
Placebo cocaine will be made available for self-administration during experimental sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Time Frame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.
9 choice trials per cocaine dose level with each trial separated by 30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joshua A. Lile, Ph.D.

Investigators

  • Principal Investigator: Joshua A Lile, Ph.D, University of Kentucky

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 16, 2013

First Submitted That Met QC Criteria

July 19, 2013

First Posted (Estimate)

July 24, 2013

Study Record Updates

Last Update Posted (Actual)

May 17, 2019

Last Update Submitted That Met QC Criteria

April 19, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DA033364-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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