CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE
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505(b)(2) Clinical Trials for Buprenorphine 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. |
| New Dosage | NCT03608696 ↗ | Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure | Completed | Chiesi Farmaceutici S.p.A. | Phase 1/Phase 2 | 2018-08-29 | Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen. |
| New Dosage | NCT03608696 ↗ | Buprenorphine Pharmacometric Open Label Research Study of Drug Exposure | Completed | Thomas Jefferson University | Phase 1/Phase 2 | 2018-08-29 | Neonatal withdrawal syndrome is a series of signs and symptoms in infants exposed to opioids in utero. Buprenorphine has demonstrated a 40% reduction in length of pharmacologic treatment compared to oral morphine. These results were with an empirically derived dose. This study will use pharmacokinetic modeling-informed dosing to clarify the dose/response relationship and use a rational approach to define an optimal dose regimen. The clinical trial will be open label, single arm design with a goal of initial testing of a new dosing regimen. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Buprenorphine Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000200 ↗ | Cocaine Effects in Humans: Physiology and Behavior - 1 | Completed | Columbia University | Phase 2 | 1997-01-01 | The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users. |
| NCT00000200 ↗ | Cocaine Effects in Humans: Physiology and Behavior - 1 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1997-01-01 | The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users. |
| NCT00000202 ↗ | Buprenorphine Maintenance for Opioid Addicts - 1 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1988-08-01 | The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence. |
| NCT00000202 ↗ | Buprenorphine Maintenance for Opioid Addicts - 1 | Completed | Yale University | Phase 2 | 1988-08-01 | The purpose of this study is to evaluate the efficacy of buprenorphine and desipramine in treatment of opiate and cocaine dependence. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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