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NCT01906346 Clinical Trial

Impact of a Non-Drug Choice on Cocaine Reinforcement

Cocaine Dependence Clinical Trial

Official title:
Impact of a Non-Drug Choice on Cocaine Reinforcement

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01906346
Other study ID # R01DA033364-01
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date January 2014
Est. completion date June 2015

Study information
Verified date April 2019
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date June 2015
Est. primary completion date June 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Cocaine
Three active doses of cocaine will be made available for self-administration during experimental sessions.
• Placebo
Placebo cocaine will be made available for self-administration during experimental sessions.

Locations
Country Name City State
United States Laboratory of Human Behavioral Pharmacology Lexington Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Joshua A. Lile, Ph.D.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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