Vigabatrin for Treatment of Cocaine Dependence
1 other identifier
interventional
186
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2008
Longer than P75 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 28, 2008
CompletedFirst Posted
Study publicly available on registry
February 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedResults Posted
Study results publicly available
June 12, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedApril 13, 2016
March 1, 2016
1.3 years
January 28, 2008
April 13, 2012
March 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 13
Study Arms (2)
1
EXPERIMENTAL3 Vigabatrin Tablets, 500 mg, bid, for 9 weeks
2
PLACEBO COMPARATOR3 Placebo Tablets, bid, for 9 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Addiction Treatment Clinic
Little Rock, Arkansas, United States
St. Luke's Hospital Addiction Pharmacology Research Laboratory
San Francisco, California, 94110, United States
Friends Research Institute
Torrance, California, United States
Operation PAR
Largo, Florida, United States
Segal Institute for Clinical Research
North Miami, Florida, 33161, United States
Johns Hopkins Bayview Medical Center Center for Chemical Dependence
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
New York University Mental Health and Addictive Disorders Research Program
New York, New York, United States
Cincinnati Addiction Research Center (CinARC)
Cincinnati, Ohio, United States
Dayton Veterans Affairs Medical Center
Dayton, Ohio, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
Related Publications (2)
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.
PMID: 23575810DERIVEDBerezina 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.
PMID: 22704138DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Lack of subject medication compliance, site-to-site variability in medication compliance possibly indicative of differing site capabilities to attract subjects sufficiently motivated to stop using cocaine.
Results Point of Contact
- Title
- M Douglas Winship
- Organization
- Catalyst Pharmaceutical Partners, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Eugene Somoza, MD, PhD
University of Cincinnati
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2008
First Posted
February 8, 2008
Study Start
January 1, 2008
Primary Completion
May 1, 2009
Study Completion
October 1, 2012
Last Updated
April 13, 2016
Results First Posted
June 12, 2012
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share