A Multi-Center Trial of Nepicastat for Cocaine Dependence

Phase 2

Completed

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

• Registration Number: NCT01704196
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-17
• Study First Submitted QC: 2012-10-09
• Study First Posted: 2012-10-11
• Study Start: 2013-04
• Primary Completion: 2014-08
• Study Completion: 2014-12
• Results First Submitted: 2017-01-04
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-07
• Last Update Submitted: 2017-04-07
• Results First Posted: 2017-05-18
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 179

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nepicastat	Nepicastat	Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
Placebo	Placebo	Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.

Primary Outcome Measures

Name	Time	Method
Abstinence (Weeks 10 - 11)	Weeks 10 - 11	Number of subjects that abstained from cocaine from weeks 10 through 11

Secondary Outcome Measures

Name	Time	Method
Reduction in Use (Weeks 1 - 11)	Baseline through week 11	Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11

Trial Locations

Locations (10)

VA Medical Center - Denver, CO; 🇺🇸 Denver, Colorado, United States

Cincinnati Addiction Research Center; 🇺🇸 Cincinnati, Ohio, United States

Mountain Manor Treatment Center at Baltimore; 🇺🇸 Baltimore, Maryland, United States

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Matrix Institute on Addictions; 🇺🇸 Los Angeles, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

George E. Wahlen VA Medical Center; 🇺🇸 Salt Lake City, Utah, United States

Pacific Institute for Research and Evaluation; 🇺🇸 Albuquerque, New Mexico, United States

University of Pennsylvania - Treatment Research Center; 🇺🇸 Philadelphia, Pennsylvania, United States