A Multi-Center Trial of Nepicastat for Cocaine Dependence

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2014-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cocaine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Nepicastat

Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks

Group Type ACTIVE_COMPARATOR

Nepicastat

Intervention Type 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

Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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