Vigabatrin for the Treatment of Cocaine Dependency

Phase 2

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
CPP-109 Vigabatrin Tablets	Vigabatrin	Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)
Placebo	Matching Placebo	Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)

Primary Outcome Measures

Name	Time	Method
Abstinence	Weeks 8-9	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).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Cocaine Use	Week 3 - 9

Locations (13): Mountain Manor Treatment Center @ Baltimore
🇺🇸
Baltimore, Maryland, United States
Medical University of South Carolina
🇺🇸
Charleston, South Carolina, United States
Matrix Institute on Addictions
🇺🇸
Los Angeles, California, United States
Friends Research Institute
🇺🇸
Torrance, California, United States
University of Miami School of Medicine
🇺🇸
Miami, Florida, United States
NeuroPsychiatric Research & Practice Assoc., Ltd.
🇺🇸
Oak Brook, Illinois, United States
Boston University School of Medicine
🇺🇸
Boston, Massachusetts, United States
Pacific Institute for Research and Evaluation
🇺🇸
Albuquerque, New Mexico, United States
Western Psychiatric Inst. and Clinic
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Pittsburgh, Pennsylvania, United States
University of Texas Health Science Center at Houston
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Houston, Texas, United States
Pillar Clinical Research, LLC
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Dallas, Texas, United States
George E Wahlen VA Medical Center
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Salt Lake City, Utah, United States
VA Medical Center
🇺🇸
Denver, Colorado, United States