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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 20, 1999 | ||||||||
| Last Updated Date | July 8, 2009 | ||||||||
| Start Date ICMJE | August 1995 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Amount drug self-administered [ Time Frame: 90 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00000273 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Subjective responses [ Time Frame: 90 min ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Laboratory Model for Heroin Abuse Medications - 8 | ||||||||
| Official Title ICMJE | A Laboratory Model for Heroin Abuse Medications | ||||||||
| Brief Summary | The purpose of this study is to evaluate the effects of treatment medications (methadone, buprenorphine, LAAM, naltrexone, naltrexone microcapsules, and methoclocinnamox) on I.V. and smoked heroin self-administration." |
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| Detailed Description | |||||||||
| Study Phase | Phase II | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacodynamics Study | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: opiates | ||||||||
| 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 | 37 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Please contact site for 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 | NCT00000273 | ||||||||
| Responsible Party | Sandra D. Comer, PhD, Columbia University and the New York State Psychiatric Institute | ||||||||
| Study ID Numbers ICMJE | NIDA-09236-8, P50 DA009236-08 | ||||||||
| Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | ||||||||
| Collaborators ICMJE | New York State Psychiatric Institute | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||||||
| Verification Date | July 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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