A Multi-Center Trial of Nepicastat for Cocaine Dependence

April 7, 2017 updated by: National Institute on Drug Abuse (NIDA)

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

179

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90016
        • Matrix Institute on Addictions
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Medical Center - Denver, CO
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Mountain Manor Treatment Center at Baltimore
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pacific Institute for Research and Evaluation
    • New York
      • New York, New York, United States, 10019
        • Columbia University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45220
        • Cincinnati Addiction Research Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania - Treatment Research Center
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • George E. Wahlen VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nepicastat
Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks
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 Comparator: Placebo
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence (Weeks 10 - 11)
Time Frame: Weeks 10 - 11
Number of subjects that abstained from cocaine from weeks 10 through 11
Weeks 10 - 11

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in Use (Weeks 1 - 11)
Time Frame: Baseline through week 11
Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11
Baseline through week 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 17, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

May 18, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA/VA CS#1031

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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