Vigabatrin for the Treatment of Cocaine Dependency

Catalyst Pharmaceuticals, Inc.207 enrolled

Overview

The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling. There are 3 Phases to this study: * a 2-4 week Screening/Baseline Phase during which eligibility to be included in the trial will be tested; * a 9 week Treatment Phase during which subjects will receive CPP-109 or placebo tablets in addition to counseling; and * a 15 week Follow-up Phase, during the first 4 weeks (Weeks 10-13) of which subjects will continue to receive counseling.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

207

Conditions

Cocaine Addiction Cocaine Dependence

Interventions

VigabatrinDRUG

Tablets

Matching PlaceboDRUG

Tablets

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Able to understand the study and provide written informed consent. * Male or female at least 18 years of age. * Meet DSM-IV criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse Structured Clinical Interview (SCID) for Diagnostic and Statistical Manual-IV (DSM-IV) module. * Have a verifiable place of primary residence. * Seeking treatment for cocaine dependence. * Be in generally good health based on history, physical examination, electrocardiogram, eye exam and laboratory findings. * If female of childbearing potential, use acceptable contraceptive methods (oral contraceptives (the pill), intrauterine device (IUD), contraceptive implants under the skin, contraceptive rings or patches or injections, diaphragms with spermicide, and condoms with spermicide). Surgical sterilization by tubal ligation or hysterectomy is acceptable. Exclusion Criteria: * Please contact site for more information

Locations (13)

Matrix Institute on Addictions

Los Angeles, California, United States

Friends Research Institute

Torrance, California, United States

VA Medical Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Abstinence

The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9).

Time frame: Weeks 8-9

Secondary Outcomes

Number of Participants With Cocaine Use

Time frame: Week 3 - 9

Data from ClinicalTrials.gov

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