Vigabatrin for the Treatment of Cocaine Dependency
Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
2 other identifiers
interventional
207
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2011
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedResults Posted
Study results publicly available
February 23, 2016
CompletedMay 18, 2016
May 1, 2016
1.8 years
January 20, 2011
February 2, 2016
May 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Weeks 8-9
Secondary Outcomes (1)
Number of Participants With Cocaine Use
Week 3 - 9
Study Arms (2)
CPP-109 Vigabatrin Tablets
ACTIVE COMPARATORSubjects 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
PLACEBO COMPARATORSubjects 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Please contact site for more information
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Catalyst Pharmaceuticals, Inc.lead
- National Institute on Drug Abuse (NIDA)collaborator
- VA Office of Research and Developmentcollaborator
Study Sites (13)
Matrix Institute on Addictions
Los Angeles, California, 90016, United States
Friends Research Institute
Torrance, California, 90502, United States
VA Medical Center
Denver, Colorado, 80220, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
NeuroPsychiatric Research & Practice Assoc., Ltd.
Oak Brook, Illinois, 60523, United States
Mountain Manor Treatment Center @ Baltimore
Baltimore, Maryland, 21229, United States
Boston University School of Medicine
Boston, Massachusetts, 02118, United States
Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, 87102, United States
Western Psychiatric Inst. and Clinic
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29403, United States
Pillar Clinical Research, LLC
Dallas, Texas, 75243, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77054, United States
George E Wahlen VA Medical Center
Salt Lake City, Utah, 84148, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- David McCann, Ph.D.
- Organization
- National Institute on Drug Abuse
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Brady, MD, PhD
Medical University of South Carolina
- STUDY CHAIR
Christopher J Stock, PharmD
George E. Wahlen VA Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
January 1, 2011
Primary Completion
October 1, 2012
Study Completion
December 1, 2012
Last Updated
May 18, 2016
Results First Posted
February 23, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share