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Vigabatrin for Treatment of Cocaine Dependence

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
vigabatrin
placebo
Sponsored by
Catalyst Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence focused on measuring Cocaine, Addiction, Dependence, Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Addiction Treatment Clinic
  • St. Luke's Hospital Addiction Pharmacology Research Laboratory
  • Friends Research Institute
  • Operation PAR
  • Segal Institute for Clinical Research
  • Johns Hopkins Bayview Medical Center Center for Chemical Dependence
  • Boston University School of Medicine
  • New York University Mental Health and Addictive Disorders Research Program
  • Cincinnati Addiction Research Center (CinARC)
  • Dayton Veterans Affairs Medical Center
  • University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks

3 Placebo Tablets, bid, for 9 weeks

Outcomes

Primary Outcome Measures

Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.
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.

Secondary Outcome Measures

Full Information

First Posted
January 28, 2008
Last Updated
March 14, 2016
Sponsor
Catalyst Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00611130
Brief Title
Vigabatrin for Treatment of Cocaine Dependence
Official Title
Vigabatrin for Treatment of Cocaine Dependence: A Phase II Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalyst Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence
Keywords
Cocaine, Addiction, Dependence, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
3 Placebo Tablets, bid, for 9 weeks
Intervention Type
Drug
Intervention Name(s)
vigabatrin
Other Intervention Name(s)
CPP-109, VGB, GVG
Intervention Description
Tablets twice a day for 9 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
tablets twice daily for 9 weeks
Primary Outcome Measure Information:
Title
Proportion of Subjects in Each Treatment Group Abstinent During the Last 2 Weeks of Treatment.
Description
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.
Time Frame
Week 13

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eugene Somoza, MD, PhD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
Addiction Treatment Clinic
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
St. Luke's Hospital Addiction Pharmacology Research Laboratory
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Friends Research Institute
City
Torrance
State/Province
California
Country
United States
Facility Name
Operation PAR
City
Largo
State/Province
Florida
Country
United States
Facility Name
Segal Institute for Clinical Research
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center Center for Chemical Dependence
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Boston University School of Medicine
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
New York University Mental Health and Addictive Disorders Research Program
City
New York
State/Province
New York
Country
United States
Facility Name
Cincinnati Addiction Research Center (CinARC)
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Dayton Veterans Affairs Medical Center
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23575810
Citation
Somoza EC, Winship D, Gorodetzky CW, Lewis D, Ciraulo DA, Galloway GP, Segal SD, Sheehan M, Roache JD, Bickel WK, Jasinski D, Watson DW, Miller SR, Somoza P, Winhusen T. A multisite, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of vigabatrin for treating cocaine dependence. JAMA Psychiatry. 2013 Jun;70(6):630-7. doi: 10.1001/jamapsychiatry.2013.872.
Results Reference
derived
PubMed Identifier
22704138
Citation
Berezina TL, Khouri AS, Winship MD, Fechtner RD. Visual field and ocular safety during short-term vigabatrin treatment in cocaine abusers. Am J Ophthalmol. 2012 Aug;154(2):326-332.e2. doi: 10.1016/j.ajo.2012.02.026. Epub 2012 Jun 15.
Results Reference
derived

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Vigabatrin for Treatment of Cocaine Dependence

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