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NCT01704196 Clinical Trial

A Multi-Center Trial of Nepicastat for Cocaine Dependence

Cocaine Dependence Clinical Trial

Official title:
Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01704196
Other study ID # NIDA/VA CS#1031
Secondary ID
Status Completed
Phase Phase 2
First received September 17, 2012
Last updated March 4, 2015
Start date April 2013
Est. completion date December 2014

Study information
Verified date March 2015
Source National Institute on Drug Abuse (NIDA)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.

Recruitment information / eligibility
Status Completed
Enrollment 179
Est. completion date December 2014
Est. primary completion date August 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Be at least 18 years of age

- Is seeking treatment for cocaine dependence

- Is able to understand and provide written informed consent

- Has completed all psychological assessments and procedures required during the 7 - 14 day screening period

- If female, agrees to use an acceptable method of birth control

- Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study

Exclusion Criteria:

- Please contact the study site for more information

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nepicastat
120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
• Placebo

Locations
Country Name City State
United States Pacific Institute for Research and Evaluation Albuquerque New Mexico
United States Mountain Manor Treatment Center at Baltimore Baltimore Maryland
United States Cincinnati Addiction Research Center Cincinnati Ohio
United States VA Medical Center - Denver, CO Denver Colorado
United States Michael E. DeBakey VA Medical Center Houston Texas
United States Matrix Institute on Addictions Los Angeles California
United States Columbia University Medical Center New York New York
United States University of Pennsylvania - Treatment Research Center Philadelphia Pennsylvania
United States George E. Wahlen VA Medical Center Salt Lake City Utah
United States VA San Diego Healthcare System San Diego California

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Treatment success or failure Subject will provide at least 2 urine samples within the given week. Week 11 No
Secondary Weekly Mean Urine BE Level A weekly mean urine BE level will be determine for each subject from the quantitative assay of BE values for each urine sample. Up to 11 weeks No
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