Vigabatrin for the Treatment of Cocaine Dependency

NCT ID: NCT01281202

Last Updated: 2016-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 207 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

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.

Conditions

Cocaine Addiction; Cocaine Dependence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CPP-109 Vigabatrin Tablets

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)

Group Type: ACTIVE_COMPARATOR

Vigabatrin

Intervention Type: DRUG

Tablets

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)

Group Type: PLACEBO_COMPARATOR

Matching Placebo

Intervention Type: DRUG

Tablets

Interventions

Vigabatrin

Tablets

Intervention Type: DRUG

Matching Placebo

Tablets

Intervention Type: DRUG

Other Intervention Names

CPP-109; GVG; VGB

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

VA Office of Research and Development

FED

Sponsor Role: collaborator

Catalyst Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathleen Brady, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Christopher J Stock, PharmD

Role: STUDY_CHAIR

George E. Wahlen VA Medical Center

Locations

Matrix Institute on Addictions

Los Angeles, California, United States

Friends Research Institute

Torrance, California, United States

VA Medical Center

Denver, Colorado, United States

University of Miami School of Medicine

Miami, Florida, United States

NeuroPsychiatric Research & Practice Assoc., Ltd.

Oak Brook, Illinois, United States

Mountain Manor Treatment Center @ Baltimore

Baltimore, Maryland, 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

Pittsburgh, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Pillar Clinical Research, LLC

Dallas, Texas, United States

University of Texas Health Science Center at Houston

Houston, Texas, United States

George E Wahlen VA Medical Center

Salt Lake City, Utah, United States

Countries

United States

Other Identifiers

Y1-DA4006

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CPP-01005/CS# 1030 TRANSFERRED

Identifier Type: -

Identifier Source: org_study_id