Vigabatrin for the Treatment of Cocaine Dependency

May 16, 2016 updated by: Catalyst Pharmaceuticals, Inc.

Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90016
        • Matrix Institute on Addictions
      • Torrance, California, United States, 90502
        • Friends Research Institute
    • Colorado
      • Denver, Colorado, United States, 80220
        • VA Medical Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami School of Medicine
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • NeuroPsychiatric Research & Practice Assoc., Ltd.
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Mountain Manor Treatment Center @ Baltimore
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Pacific Institute for Research and Evaluation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Western Psychiatric Inst. and Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, United States, 75243
        • Pillar Clinical Research, LLC
      • Houston, Texas, United States, 77054
        • University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84148
        • George E Wahlen VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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)
Drug: Vigabatrin
Tablets
Other Names:
  • CPP-109
  • GVG
  • VGB
Placebo Comparator: 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)
Drug: Matching Placebo
Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abstinence
Time Frame: 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).
Weeks 8-9

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With Cocaine Use
Time Frame: Week 3 - 9
Week 3 - 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalyst Pharmaceuticals, Inc.

Collaborators

National Institute on Drug Abuse (NIDA)
VA Office of Research and Development

Investigators

  • Principal Investigator: Kathleen Brady, MD, PhD, Medical University of South Carolina
  • Study Chair: Christopher J Stock, PharmD, George E. Wahlen VA Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 20, 2011

First Submitted That Met QC Criteria

January 20, 2011

First Posted (Estimate)

January 21, 2011

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 16, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPP-01005/CS# 1030 TRANSFERRED
  • Y1-DA4006 (Other Grant/Funding Number: NIDA/VA CSP #1030)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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