Impact of a Non-Drug Choice on Cocaine Reinforcement
1 other identifier
interventional
9
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
May 17, 2019
CompletedMay 17, 2019
April 1, 2019
1.4 years
July 16, 2013
April 19, 2019
April 19, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
9 choice trials per cocaine dose level with each trial separated by 30 minutes
Study Arms (3)
Low Value Alternative Reinforcer
EXPERIMENTALA low value reinforcer will be made available as an alternative to cocaine and placebo.
Medium Value Reinforcer
EXPERIMENTALA medium value reinforcer will be made available as an alternative to cocaine and placebo.
High Value Reinforcer
EXPERIMENTALA high value reinforcer will be made available as an alternative to cocaine and placebo.
Interventions
Three active doses of cocaine will be made available for self-administration during experimental sessions.
Placebo cocaine will be made available for self-administration during experimental sessions.
Eligibility Criteria
You may qualify if:
- Cocaine dependence, otherwise healthy
You may not qualify if:
- Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40536-0086, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Joshua A. Lile, Ph.D.
- Organization
- University of Kentucky
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua A Lile, Ph.D
University of Kentucky
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Joshua A. Lile, Ph.D., Associate Professor of Behavioral Science
Study Record Dates
First Submitted
July 16, 2013
First Posted
July 24, 2013
Study Start
January 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
May 17, 2019
Results First Posted
May 17, 2019
Record last verified: 2019-04