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Last Updated: September 26, 2021

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CLINICAL TRIALS PROFILE FOR BUPRENORPHINE

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505(b)(2) Clinical Trials for Buprenorphine

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
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 Not yet recruiting 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 Not yet recruiting 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 >Phase >Start Date >Summary

All Clinical Trials for Buprenorphine

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.
NCT00000203 ↗ Buprenorphine Maintenance for Opioid Addicts - 2 Completed National Institute on Drug Abuse (NIDA) Phase 2 1988-08-01 The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence and cocaine abuse.
NCT00000203 ↗ Buprenorphine Maintenance for Opioid Addicts - 2 Completed Yale University Phase 2 1988-08-01 The purpose of this study is to evaluate varying doses of buprenorphine for opioid dependence and cocaine abuse.
NCT00000204 ↗ Buprenorphine Maintenance for Opioid Addicts - 3 Completed National Institute on Drug Abuse (NIDA) Phase 2 1988-08-01 The purpose of this study is to evaluate buprenorphine in a medical maintenance model three times a week.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Buprenorphine

Condition Name

Condition Name for Buprenorphine
Intervention Trials
Opioid-Related Disorders 93
Opioid-use Disorder 43
Opioid Dependence 35
Heroin Dependence 30
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Condition MeSH

Condition MeSH for Buprenorphine
Intervention Trials
Opioid-Related Disorders 149
Substance-Related Disorders 64
Disease 44
Heroin Dependence 33
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Clinical Trial Locations for Buprenorphine

Trials by Country

Trials by Country for Buprenorphine
Location Trials
Japan 29
United Kingdom 26
Germany 10
Canada 10
Norway 8
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Trials by US State

Trials by US State for Buprenorphine
Location Trials
New York 75
California 71
Florida 63
Pennsylvania 59
Maryland 55
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Clinical Trial Progress for Buprenorphine

Clinical Trial Phase

Clinical Trial Phase for Buprenorphine
Clinical Trial Phase Trials
Phase 4 78
Phase 3 98
Phase 2/Phase 3 15
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Clinical Trial Status

Clinical Trial Status for Buprenorphine
Clinical Trial Phase Trials
Completed 236
Not yet recruiting 82
Recruiting 52
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Clinical Trial Sponsors for Buprenorphine

Sponsor Name

Sponsor Name for Buprenorphine
Sponsor Trials
National Institute on Drug Abuse (NIDA) 143
Yale University 31
Indivior Inc. 28
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Sponsor Type

Sponsor Type for Buprenorphine
Sponsor Trials
Other 407
Industry 171
NIH 152
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