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Last Updated: October 23, 2020

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CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Buprenorphine Hydrochloride

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 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Buprenorphine Hydrochloride

Condition Name

Condition Name for Buprenorphine Hydrochloride
Intervention Trials
Opioid-related Disorders 93
Opioid-use Disorder 36
Opioid Dependence 34
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Condition MeSH

Condition MeSH for Buprenorphine Hydrochloride
Intervention Trials
Opioid-Related Disorders 147
Substance-Related Disorders 58
Disease 43
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Clinical Trial Locations for Buprenorphine Hydrochloride

Trials by Country

Trials by Country for Buprenorphine Hydrochloride
Location Trials
Japan 29
United Kingdom 26
Germany 10
Norway 8
Denmark 7
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Trials by US State

Trials by US State for Buprenorphine Hydrochloride
Location Trials
New York 74
California 71
Florida 63
Pennsylvania 58
Maryland 54
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Clinical Trial Progress for Buprenorphine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Buprenorphine Hydrochloride
Clinical Trial Phase Trials
Phase 4 74
Phase 3 98
Phase 2/Phase 3 12
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Clinical Trial Status

Clinical Trial Status for Buprenorphine Hydrochloride
Clinical Trial Phase Trials
Completed 236
Not yet recruiting 68
Recruiting 50
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Clinical Trial Sponsors for Buprenorphine Hydrochloride

Sponsor Name

Sponsor Name for Buprenorphine Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 139
Yale University 28
Purdue Pharma LP 27
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Sponsor Type

Sponsor Type for Buprenorphine Hydrochloride
Sponsor Trials
Other 373
Industry 169
NIH 148
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