A Multi-Center Trial of Nepicastat for Cocaine Dependence

National Institute on Drug Abuse (NIDA)179 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

179

Conditions

Cocaine Dependence

Interventions

NepicastatDRUG

120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (10)

Matrix Institute on Addictions

Los Angeles, California, United States

VA San Diego Healthcare System

San Diego, California, United States

VA Medical Center - Denver, CO

Denver, Colorado, United States

Outcomes

Primary Outcomes

Abstinence (Weeks 10 - 11)

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

Time frame: Weeks 10 - 11

Secondary Outcomes

Reduction in Use (Weeks 1 - 11)

Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11

Time frame: Baseline through week 11

Data from ClinicalTrials.gov

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