Vigabatrin for the Treatment of Cocaine Dependency

Catalyst Pharmaceuticals

Status and phase: Completed; Phase 3; Phase 2

Conditions: Cocaine Dependence; Cocaine Addiction

Treatments: Drug: Matching Placebo; Drug: Vigabatrin

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency; NIH

Identifiers

NCT01281202

CPP-01005/CS# 1030 TRANSFERRED

Y1-DA4006 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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207 participants in 2 patient groups, including a placebo group

CPP-109 Vigabatrin Tablets

Active Comparator group

Description:

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)

Treatment:

Drug: Vigabatrin

Placebo

Placebo Comparator group

Description:

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)

Treatment:

Drug: Matching Placebo