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
• 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

• Cocaine Dependence
• Cocaine-Related Disorders

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