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| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | February 18, 2008 | ||||||||||||||||
| Last Updated Date | June 17, 2009 | ||||||||||||||||
| Start Date ICMJE | February 2008 | ||||||||||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
safety/tolerability and AE assessments including HR/BP/ECG/QTc [ Time Frame: 56 days ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00626834 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
VGB/PK during cocaine infusions and effect of VGB on cocaine craving [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Vigabatrin Ph 2a Cocaine Interaction Study | ||||||||||||||||
| Official Title ICMJE | A Phase 2A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study | ||||||||||||||||
| Brief Summary | This is a Phase 2a safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions. |
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| Detailed Description | STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of the effects of VGB compared to placebo control on the physiological and subjective effects of IV infusions of cocaine (cocaine experienced volunteers). Subjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will receive double-blind infusions of saline and cocaine. Subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge. STUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge. SAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo. POPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age. |
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| Study Phase | Phase II | ||||||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Design ICMJE | Basic Science, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||||||||||||||
| Condition ICMJE | Cocaine Addiction | ||||||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||||||
| Publications * | |||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 24 | ||||||||||||||||
| Estimated Completion Date | December 2010 | ||||||||||||||||
| Estimated Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Please contact site for more information. |
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 45 Years | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT ID ICMJE | NCT00626834 | ||||||||||||||||
| Responsible Party | John Roache, Ph.D., University of Texas | ||||||||||||||||
| Study ID Numbers ICMJE | OV-1014 | ||||||||||||||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||||||||||||||
| Verification Date | June 2009 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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