Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence
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ClinicalTrials.gov Identifier: NCT00527683 |
Recruitment Status
:
Completed
First Posted
: September 11, 2007
Last Update Posted
: April 11, 2008
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Sponsor:
New York University School of Medicine
Collaborator:
Catalyst Pharmaceuticals, Inc.
Information provided by:
New York University School of Medicine
Tracking Information | |||||||
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First Submitted Date ICMJE | September 10, 2007 | ||||||
First Posted Date ICMJE | September 11, 2007 | ||||||
Last Update Posted Date | April 11, 2008 | ||||||
Study Start Date ICMJE | April 2007 | ||||||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Three consecutive weeks of negative urine tests (benzoyl ecgonine) for cocaine use (no slips allowed). [ Time Frame: These must be the last three weeks (7,8,9) of the trial. ] | ||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | Complete list of historical versions of study NCT00527683 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | Double Blind Study of Vigabatrin for the Treatment of Cocaine Dependence | ||||||
Official Title ICMJE | Double-Blind, Randomized, Placebo- Controlled Trial of Vigabatrin for Short Term Abstinence From Cocaine in Cocaine Dependent Parolees | ||||||
Brief Summary | The primary objective of this study is to assess the efficacy of vigabatrin for the treatment of cocaine dependence, based on the twice-weekly qualitative urine toxicologies for cocaine. Based on two prior unblinded human studies and 15 years of animal studies, this 100 subject double- blind, randomized study is designed to show if with vigabatrin treatment but not placebo, even non-hospitalized cocaine dependent individuals with ready access to cocaine will become cocaine abstinent if they are self motivated to stop their cocaine habit. To accomplish this, cocaine dependent subjects will be randomly assigned to either a placebo or vigabatrin treatment group and treated for a nine week period. The primary hypothesis is that as compared to the placebo arm, the vigabatrin treatment arm will show a significant increase in the number of subjects who are abstinent for the final 3 weeks of the study. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cocaine Dependence | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE |
100 | ||||||
Original Actual Enrollment ICMJE | Same as current | ||||||
Actual Study Completion Date | November 2007 | ||||||
Actual Primary Completion Date | November 2007 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: In order to participate in the study, subjects must
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 55 Years (Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Mexico | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00527683 | ||||||
Other Study ID Numbers ICMJE | H06-152 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Jonathan D. Brodie, PhD, MD, Professor, Dept. of Psychiatry, New York University School of Medicine | ||||||
Study Sponsor ICMJE | New York University School of Medicine | ||||||
Collaborators ICMJE | Catalyst Pharmaceuticals, Inc. | ||||||
Investigators ICMJE |
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PRS Account | New York University School of Medicine | ||||||
Verification Date | April 2008 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |