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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 5, 2007 | ||||
| Last Updated Date | December 3, 2008 | ||||
| Start Date ICMJE | September 2007 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Safety and tolerability of modafinil in methamphetamine-dependent persons [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00569374 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Treatment retention and illicit drug use [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Safety and Tolerability of Modafinil for Methamphetmaine Dependence | ||||
| Official Title ICMJE | Safety and Tolerability of Modafinil for Methamphetamine Dependence | ||||
| Brief Summary | This 7 week, open-label pilot clinical trial will examine the safety and tolerability of modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in methamphetamine-dependent volunteers. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Methamphetamine Dependence | ||||
| Intervention ICMJE | Drug: Modafinil | ||||
| 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 | Completed | ||||
| Estimated Enrollment ICMJE | 8 | ||||
| Completion Date | |||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00569374 | ||||
| Responsible Party | Carole Hamon, University of Arkansas for Medical Sciences | ||||
| Study ID Numbers ICMJE | Protocol / IRB # 79045 | ||||
| Study Sponsor ICMJE | University of Arkansas | ||||
| Collaborators ICMJE | NIDA Baylor Medications Development Center | ||||
| Investigators ICMJE |
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| Information Provided By | University of Arkansas | ||||
| Verification Date | December 2008 | ||||
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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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