Vigabatrin for the Treatment of Cocaine Dependency

This study has been completed.
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
VA Office of Research and Development
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA) ( Catalyst Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier:
NCT01281202
First received: January 20, 2011
Last updated: May 16, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention Phase
Cocaine Addiction
Cocaine Dependence
Drug: Vigabatrin
Drug: Matching Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Abstinence [ Time Frame: Weeks 8-9 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Week 3 - 9 ] [ Designated as safety issue: No ]

Enrollment: 207
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281202

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

Responsible Party: Catalyst Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01281202     History of Changes
Other Study ID Numbers: CPP-01005/CS# 1030 TRANSFERRED  Y1-DA4006 
Study First Received: January 20, 2011
Results First Received: February 2, 2016
Last Updated: May 16, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by National Institute on Drug Abuse (NIDA):
Cocaine
Cocaine Addiction Treatment
Cocaine Treatment
Vigabatrin
CPP-109
Catalyst
National Institute on Drug Abuse

Additional relevant MeSH terms:
Behavior, Addictive
Cocaine-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Vigabatrin
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Anticonvulsants
Enzyme Inhibitors
GABA Agents

ClinicalTrials.gov processed this record on July 25, 2016