CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
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505(b)(2) Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT00637000 ↗ | Induction of Opioid-Dependent Individuals Onto Buprenorphine and Buprenorphine/Naloxone | Completed | Indivior Inc. | Phase 2 | 2008-03-01 | The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale (COWS). The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for buprenorphine hydrochloride; naloxone hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000243 ↗ | Effects of Buprenorphine/Naloxone in Treating Opioid Dependent Individuals Who Are Maintained on Methadone | Terminated | National Institute on Drug Abuse (NIDA) | N/A | 2002-09-01 | Buprenorphine is a drug that may be helpful in treating opioid dependent individuals who were previously maintained on methadone. The purpose of this study is to determine the effects of different doses of buprenorphine/naloxone in treating opioid dependent individuals who were previously maintained on methadone. |
| NCT00000298 ↗ | Buprenorphine Combination Tablet Feasibility - 1 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1995-08-01 | The purpose of this study is to determine target dose range of buprenorphine/naloxone combination tablet that provides therapeutic response in opiate addicts with low to moderate dependence, and to identify appropriate initial induction dose in opiate addicts with low to moderate dependence." |
| NCT00000326 ↗ | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1 | Withdrawn | National Institute on Drug Abuse (NIDA) | Phase 2 | 1997-04-01 | The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen. |
| NCT00000326 ↗ | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1 | Withdrawn | University of Colorado, Denver | Phase 2 | 1997-04-01 | The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone combination tablet for alternate-day dosing and determine whether multiples of the daily dose are necessary to maintain an effective alternate day dosing regimen. |
| NCT00000327 ↗ | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2 | Withdrawn | National Institute on Drug Abuse (NIDA) | Phase 2 | 1997-06-01 | The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days. |
| NCT00000327 ↗ | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2 | Withdrawn | University of Colorado, Denver | Phase 2 | 1997-06-01 | The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days. |
| NCT00000328 ↗ | Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3 | Withdrawn | National Institute on Drug Abuse (NIDA) | Phase 2 | 1997-07-01 | The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for buprenorphine hydrochloride; naloxone hydrochloride
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Clinical Trial Locations for buprenorphine hydrochloride; naloxone hydrochloride
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Clinical Trial Progress for buprenorphine hydrochloride; naloxone hydrochloride
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Clinical Trial Sponsors for buprenorphine hydrochloride; naloxone hydrochloride
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