Back to resultsImpact of a Non-Drug Choice on Cocaine Reinforcement
Primary Purpose
Cocaine Dependence
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cocaine
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Cocaine Dependence
Eligibility Criteria
Inclusion Criteria:
- Cocaine dependence, otherwise healthy
Exclusion Criteria:
- Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Sites / Locations
- Laboratory of Human Behavioral Pharmacology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Low Value Alternative Reinforcer
Medium Value Reinforcer
High Value Reinforcer
Arm Description
A low value reinforcer will be made available as an alternative to cocaine and placebo.
A medium value reinforcer will be made available as an alternative to cocaine and placebo.
A high value reinforcer will be made available as an alternative to cocaine and placebo.
Outcomes
Primary Outcome Measures
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01906346
Brief Title
Impact of a Non-Drug Choice on Cocaine Reinforcement
Official Title
Impact of a Non-Drug Choice on Cocaine Reinforcement
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joshua A. Lile, Ph.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Value Alternative Reinforcer
Arm Type
Experimental
Arm Description
A low value reinforcer will be made available as an alternative to cocaine and placebo.
Arm Title
Medium Value Reinforcer
Arm Type
Experimental
Arm Description
A medium value reinforcer will be made available as an alternative to cocaine and placebo.
Arm Title
High Value Reinforcer
Arm Type
Experimental
Arm Description
A high value reinforcer will be made available as an alternative to cocaine and placebo.
Intervention Type
Drug
Intervention Name(s)
Cocaine
Intervention Description
Three active doses of cocaine will be made available for self-administration during experimental sessions.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo cocaine will be made available for self-administration during experimental sessions.
Primary Outcome Measure Information:
Title
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Description
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.
Time Frame
9 choice trials per cocaine dose level with each trial separated by 30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cocaine dependence, otherwise healthy
Exclusion Criteria:
Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua A Lile, Ph.D
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratory of Human Behavioral Pharmacology
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0086
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Impact of a Non-Drug Choice on Cocaine Reinforcement
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