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

January 28, 2008
May 10, 2012
January 2008
May 2009   (final data collection date for primary outcome measure)
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.
The primary outcome variable is the proportion of subjects in each treatment group who are abstinent during the last 2 weeks of treatment. [ Time Frame: Week 13 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00611130 on ClinicalTrials.gov Archive Site
Not Provided
Group differences in the weekly fraction of cocaine use days divided by the sum of cocaine use and non-use days, for each of the 2 baseline weeks and for Treatment Phase Weeks 1 through 12. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Vigabatrin for Treatment of Cocaine Dependence
Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Dependence
  • Drug: vigabatrin
    Tablets twice a day for 12 weeks
    Other Name: CPP-109, VGB, GVG
  • Drug: placebo
    tablets twice daily for 12 weeks
  • Experimental: 1
    Vigabatrin Tablets
    Intervention: Drug: vigabatrin
  • Placebo Comparator: 2
    Placebo Tablets
    Intervention: Drug: placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
186
July 2009
May 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611130
CPP-01004
No
Catalyst Pharmaceutical Partners, Inc
Catalyst Pharmaceutical Partners, Inc
Not Provided
Principal Investigator: Eugene Somoza, MD, PhD University of Cincinnati
Catalyst Pharmaceutical Partners, Inc
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP