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Completed

NCT Number: NCT01704196

A 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.

Completed

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Matrix Institute on Addictions, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nepicastat

Drug

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

Drug

Primary outcomes

  1. Abstinence (Weeks 10 - 11)

    Time frame: Weeks 10 - 11

    Number of subjects that abstained from cocaine from weeks 10 through 11

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2012
Registry last updated
May 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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