Vigabatrin for the Treatment of Cocaine Dependency

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Catalyst Pharmaceutical Partners, Inc.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier:
NCT01281202
First received: January 20, 2011
Last updated: June 20, 2012
Last verified: June 2012
  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.

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.

Condition Intervention Phase
Cocaine Addiction
Cocaine Dependence
Drug: Vigabatrin
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 Catalyst Pharmaceutical Partners, Inc:

Primary Outcome Measures:
  • Abstinence [ Time Frame: Weeks 8-9 ] [ Designated as safety issue: No ]
    The proportion 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:
  • Cocaine Use Days [ Time Frame: Weeks 1-9 ] [ Designated as safety issue: No ]
    Weekly fraction of cocaine use days.

  • Clean Urines [ Time Frame: Weeks 1-9 ] [ Designated as safety issue: No ]
    Percent of clean urines (BE<300 ng/mL) collected during Treatment Phase

  • Abstinence [ Time Frame: Weeks 13-24 ] [ Designated as safety issue: No ]
    Time to exit from abstinence state up to weeks 13 & 24 among those subjects who were cocaine free in weeks 8 and 9 (durability of effect)


Estimated Enrollment: 200
Study Start Date: January 2011
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPP-109 Vigabatrin Tablets Drug: Vigabatrin
Tablets
Other Names:
  • CPP-109
  • GVG
  • VGB
Placebo Comparator: Placebo
Matching Tablet
Drug: Vigabatrin
Tablets
Other Names:
  • CPP-109
  • GVG
  • VGB

  Eligibility

Ages Eligible for Study:   18 Years and older
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 SCID (Structured Clinical Interview for 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), IUDs, 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:

  • Has current dependence on any psychoactive substance other than cocaine, alcohol, nicotine or marijuana, or physiologic dependence on alcohol requiring medical detoxification.
  • Have any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk.
  • Has uncontrolled hypertension (>140 mmHg systolic and/or >90 mmHg diastolic) based on at least 3 confirmatory readings performed at least 5 minutes apart over a one hour period with the subject sitting at rest.
  • Has ever taken vigabatrin in the past.
  • Is pregnant or lactating.
  • Has clinically significant ophthalmologic disease, which would preclude safety monitoring, is undergoing treatment for ocular disease or intends to have any ocular surgery or procedure performed during the time of their participation in the trial.
  • Is currently participating in, or has been enrolled in another clinical trial within the last 30 days.
  • Be anyone who, in the judgment of the investigator, would not be expected to attend regular study visits or to complete the study protocol, due to imminent relocation from the clinic area, legal difficulties, work-related problems, transportation, etc.
  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
Los Angeles, California, United States
Torrance, California, United States, 90502
United States, Colorado
Denver, Colorado, United States
United States, Florida
Miami, Florida, United States
United States, Illinois
Oak Brook, Illinois, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
Sponsors and Collaborators
Catalyst Pharmaceutical Partners, Inc
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

No publications provided

Responsible Party: Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier: NCT01281202     History of Changes
Other Study ID Numbers: CPP-01005/CS# 1030, CPP-01005, CS# 1030
Study First Received: January 20, 2011
Last Updated: June 20, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Catalyst Pharmaceutical Partners, Inc:
Cocaine
Cocaine Addiction Treatment
Cocaine Treatment
Vigabatrin
CPP-109
Catalyst
NIDA

Additional relevant MeSH terms:
Cocaine-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Cocaine
Vigabatrin
Anesthetics
Anesthetics, Local
Anticonvulsants
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Uptake Inhibitors
Enzyme Inhibitors
GABA Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on October 30, 2014