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| Descriptive Information Fields | |||||
| Brief Title † | Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution - 1 | ||||
| Official Title † | Buprenorphine Formulation Comparison: Sublingual Tablet Vs. Solution | ||||
| Brief Summary | The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form." |
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| Detailed Description | 1) Compare subjects response to liquid vs tablet formulation 2) Assess bioequivalency of liquid vs tablet 3)Compare subject preference 4) Evaluate if dose response curve for tablet = to liquid form |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Double-Blind, Crossover Assignment | ||||
| Primary Outcome Measure † | Craving Drug use Withdrawal symptoms |
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| Secondary Outcome Measure † | |||||
| Condition † | Opioid-Related Disorders | ||||
| Intervention † | Drug: Buprenorphine | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Active, not recruiting | ||||
| Enrollment † | 0 | ||||
| Start Date † | October 1997 | ||||
| Completion Date | |||||
| Eligibility Criteria † | Inclusion Criteria: M/F ages 18-65. Meet DMS-IV criteria for opiate dependence. Agree to conditions of the study and sign informed consent. Exclusion Criteria: Pregnant or nursing women. Acute medical condition that would interfere with study participation or put safety of subjects in jeopardy. Current daily use of anti-convulsants, antabuse or neuroleptics. DSM-IV diagnosis of ETOH or sedative/hypnotics dependence. |
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00000320 | ||||
| Organization ID | NIDA-10068-1 | ||||
| Secondary IDs †† | R01-10068-1 | ||||
| Study Sponsor † | National Institute on Drug Abuse (NIDA) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute on Drug Abuse (NIDA) | ||||
| Verification Date | October 1997 | ||||
| First Received Date † | September 20, 1999 | ||||
| Last Updated Date | June 23, 2005 | ||||
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