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| Tracking Information | |||||
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| First Received Date ICMJE | September 20, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
| Start Date ICMJE | April 1996 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00000343 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brain Changes in Stimulant Dependent Subjects - 8 | ||||
| Official Title ICMJE | Brain Changes in Stimulant Dependent Subjects | ||||
| Brief Summary | The purpose of this study is to identify the neurophysiologic indicators of cocaine or methamphetamine use and withdrawal, to examine the relationship between subjects' reports of depression, craving, and stimulant use, and neurophysiologic measures, and to identify neurophysiologic measures which can be used to identify new treatments for stimulant dependence. |
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| Detailed Description | By Incorporating QEEG into clinical trails, the plan is to develop physiologic markers of treatment efficacy, and to aid in the identification of effective treatments. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Substance-Related Disorders | ||||
| Intervention ICMJE | |||||
| 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 | Active, not recruiting | ||||
| Enrollment ICMJE | 90 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: M/F ages 21-50. Meet DSM-IV criteria for cocaine dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nuring women. Dependence on ETOH or benzodiazepines or other sedative/hypnotics. Acute hepatitis. Other medical condtions that deem participation to be unsafe. |
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| Gender | Both | ||||
| Ages | 21 Years to 50 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00000343 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | NIDA-3-0010-8, Y01-3-0010-8 | ||||
| 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 | April 1996 | ||||
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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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