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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02383043
Other study ID # R01DA033364-02
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 1, 2015
Est. completion date April 5, 2018

Study information

Verified date March 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 choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date April 5, 2018
Est. primary completion date April 5, 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years to 45 Years
Eligibility Inclusion Criteria:

- Recent cocaine use, 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

Sustained Release d-Amphetamine


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 (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance. 9 choice trials per cocaine dose level with each trial separated by 30 minutes