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A Multi-Center Trial of Nepicastat for Cocaine Dependence

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01704196
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : May 18, 2017
Last Update Posted : May 18, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cocaine Dependence Drug: Nepicastat Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence
Study Start Date : April 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : December 2014
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Abstinence (Weeks 10 - 11) [ Time Frame: Weeks 10 - 11 ]
    Number of subjects that abstained from cocaine from weeks 10 through 11


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704196


Locations
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United States, California
Matrix Institute on Addictions
Los Angeles, California, United States, 90016
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Colorado
VA Medical Center - Denver, CO
Denver, Colorado, United States, 80220
United States, Maryland
Mountain Manor Treatment Center at Baltimore
Baltimore, Maryland, United States, 21229
United States, New Mexico
Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, United States, 87102
United States, New York
Columbia University Medical Center
New York, New York, United States, 10019
United States, Ohio
Cincinnati Addiction Research Center
Cincinnati, Ohio, United States, 45220
United States, Pennsylvania
University of Pennsylvania - Treatment Research Center
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
United States, Utah
George E. Wahlen VA Medical Center
Salt Lake City, Utah, United States, 84148
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
More Information
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01704196    
Other Study ID Numbers: NIDA/VA CS#1031
First Posted: October 11, 2012    Key Record Dates
Results First Posted: May 18, 2017
Last Update Posted: May 18, 2017
Last Verified: April 2017
Additional relevant MeSH terms:
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Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders