Vigabatrin for Treatment of Cocaine Dependence

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier:
NCT00611130
First received: January 28, 2008
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

The objective of this study is to demonstrate that a larger proportion of vigabatrin-treated subjects than placebo-treated subjects will be cocaine-free in the last 2 weeks of treatment.


Condition Intervention Phase
Cocaine Dependence
Drug: vigabatrin
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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:
  • Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment. [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
    Number of subjects in the CPP-109 Vigabatrin Group vs. Number in Placebo Group abstinent from using cocaine during Weeks 11 and 12 of the Treatment Phase.


Enrollment: 186
Study Start Date: January 2008
Study Completion Date: July 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Vigabatrin Tablets
Drug: vigabatrin
Tablets twice a day for 12 weeks
Other Name: CPP-109, VGB, GVG
Placebo Comparator: 2
Placebo Tablets
Drug: placebo
tablets twice daily for 12 weeks

Detailed Description:

Cocaine addiction, a serious public health concern associated with significant medical, social, and economic consequences, is difficult to treat using traditional psychosocial and behavioral therapies. Despite testing of a number of different agents for cocaine dependency, there remains no proven pharmacologic treatment for cocaine addiction.

The addictive properties of cocaine have been associated with its actions on mesotelencephalic dopamine reward pathways in the central nervous system (CNS). Cocaine administration increases the levels of dopamine, a neurotransmitter associated with sensations of pleasure and reward. Therefore, blocking cocaine-induced increases in dopamine levels represents a valid pharmaceutical approach to the treatment of cocaine addiction.

Another neurotransmitter, gamma-aminobutyric acid (GABA), suppresses striatal dopamine release, and attenuates cocaine-induced increases in extracellular and synaptic dopamine levels in the striatum and nucleus accumbens in animal models of drug dependence. Significant elevation of brain GABA levels may reduce cocaine-stimulated dopamine release and dampen the sensations of pleasure and reward. Thus, drugs that potentiate or enhance GABA-ergic transmission are candidates for the treatment of cocaine addiction.

  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.
  • Meets DSM-IV (Diagnostic and Statistical Manual of Mental Disorders Fourth Edition) criteria for cocaine dependence as primary diagnosis, as determined by the Substance Abuse module of SCID (Structured Clinical Interview for DSM-IV).
  • Provide at least one urine sample that is positive for cocaine according to a rapid screening test.
  • Seeking treatment for cocaine dependence.
  • Have normal visual fields.
  • Be in generally good health based on history, physical examination, electrocardiogram 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, as determined by the SCID, on any psychoactive substance other than cocaine, alcohol, nicotine, or marijuana or physiologic dependence on alcohol requiring medical detoxification.
  • Has 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.
  • Be under court mandate to obtain treatment.
  • Be enrolled in an opiate substitution treatment program within 2 months of randomization.
  • Has ever taken vigabatrin in the past.
  • Is pregnant or lactating.
  • Has clinically significant ophthalmologic disease, which would preclude safety monitoring or is undergoing treatment for ocular disease.
  • Has received a drug with known major organ toxicity, including retinotoxicity within 30 days of randomization.
  • 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: NCT00611130

Locations
United States, Arkansas
Addiction Treatment Clinic
Little Rock, Arkansas, United States
United States, California
St. Luke's Hospital Addiction Pharmacology Research Laboratory
San Francisco, California, United States, 94110
Friends Research Institute
Torrance, California, United States
United States, Florida
Operation PAR
Largo, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
United States, Maryland
Johns Hopkins Bayview Medical Center Center for Chemical Dependence
Baltimore, Maryland, United States
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States
United States, New York
New York University Mental Health and Addictive Disorders Research Program
New York, New York, United States
United States, Ohio
Cincinnati Addiction Research Center (CinARC)
Cincinnati, Ohio, United States
Dayton Veterans Affairs Medical Center
Dayton, Ohio, United States
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Sponsors and Collaborators
Catalyst Pharmaceutical Partners, Inc
Investigators
Principal Investigator: Eugene Somoza, MD, PhD University of Cincinnati
  More Information

No publications provided by Catalyst Pharmaceutical Partners, Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catalyst Pharmaceutical Partners, Inc
ClinicalTrials.gov Identifier: NCT00611130     History of Changes
Other Study ID Numbers: CPP-01004
Study First Received: January 28, 2008
Results First Received: April 13, 2012
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Catalyst Pharmaceutical Partners, Inc:
Cocaine
Addiction
Dependence
Treatment

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

ClinicalTrials.gov processed this record on September 11, 2014