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Vigabatrin for the Treatment of Cocaine Dependency

Primary Purpose

Cocaine Addiction, Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vigabatrin
Matching Placebo
Sponsored by
Catalyst Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Addiction focused on measuring Cocaine, Cocaine Addiction Treatment, Cocaine Treatment, Vigabatrin, CPP-109, Catalyst, National Institute on Drug Abuse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Matrix Institute on Addictions
  • Friends Research Institute
  • VA Medical Center
  • University of Miami School of Medicine
  • NeuroPsychiatric Research & Practice Assoc., Ltd.
  • Mountain Manor Treatment Center @ Baltimore
  • Boston University School of Medicine
  • Pacific Institute for Research and Evaluation
  • Western Psychiatric Inst. and Clinic
  • Medical University of South Carolina
  • Pillar Clinical Research, LLC
  • University of Texas Health Science Center at Houston
  • George E Wahlen VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

CPP-109 Vigabatrin Tablets

Placebo

Arm 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)

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)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Number of Participants With Cocaine Use

Full Information

First Posted
January 20, 2011
Last Updated
May 16, 2016
Sponsor
Catalyst Pharmaceuticals, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT01281202
Brief Title
Vigabatrin for the Treatment of Cocaine Dependency
Official Title
Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalyst Pharmaceuticals, Inc.
Collaborators
National Institute on Drug Abuse (NIDA), VA Office of Research and Development

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Addiction, Cocaine Dependence
Keywords
Cocaine, Cocaine Addiction Treatment, Cocaine Treatment, Vigabatrin, CPP-109, Catalyst, National Institute on Drug Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
207 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPP-109 Vigabatrin Tablets
Arm Type
Active Comparator
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Vigabatrin
Other Intervention Name(s)
CPP-109, GVG, VGB
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Tablets
Primary Outcome Measure Information:
Title
Abstinence
Description
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 Outcome Measure Information:
Title
Number of Participants With Cocaine Use
Time Frame
Week 3 - 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Brady, MD, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christopher J Stock, PharmD
Organizational Affiliation
George E. Wahlen VA Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Matrix Institute on Addictions
City
Los Angeles
State/Province
California
ZIP/Postal Code
90016
Country
United States
Facility Name
Friends Research Institute
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
VA Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
NeuroPsychiatric Research & Practice Assoc., Ltd.
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Mountain Manor Treatment Center @ Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Pacific Institute for Research and Evaluation
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Western Psychiatric Inst. and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
Pillar Clinical Research, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243
Country
United States
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
George E Wahlen VA Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Vigabatrin for the Treatment of Cocaine Dependency

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