Impact of a Non-Drug Choice on Cocaine Reinforcement

Early Phase 1

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Cocaine; Drug: Placebo

• Registration Number: NCT01906346
• Lead Sponsor: Joshua A. Lile, Ph.D.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-19
• Study First Posted: 2013-07-24
• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2019-04
• Results First Submitted: 2019-04-19
• Results First Submitted QC: 2019-04-19
• Last Update Submitted: 2019-04-19
• Results First Posted: 2019-05-17
• Last Update Posted: 2019-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Value Alternative Reinforcer	Placebo	A low value reinforcer will be made available as an alternative to cocaine and placebo.
High Value Reinforcer	Placebo	A high value reinforcer will be made available as an alternative to cocaine and placebo.
Medium Value Reinforcer	Cocaine	A medium value reinforcer will be made available as an alternative to cocaine and placebo.
Medium Value Reinforcer	Placebo	A medium value reinforcer will be made available as an alternative to cocaine and placebo.
Low Value Alternative Reinforcer	Cocaine	A low value reinforcer will be made available as an alternative to cocaine and placebo.
High Value Reinforcer	Cocaine	A high value reinforcer will be made available as an alternative to cocaine and placebo.

Primary Outcome Measures

Name	Time	Method
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative	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.

Trial Locations

Locations (1)

Laboratory of Human Behavioral Pharmacology; 🇺🇸 Lexington, Kentucky, United States