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Last Updated: September 23, 2021

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CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Buprenorphine Hydrochloride; Naloxone 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.
>Trial Type >Trial ID >Title >Status >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 Completed 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 Completed 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Condition Name

Condition Name for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Intervention Trials
Opioid-Related Disorders 29
Opioid Dependence 15
Opioid-use Disorder 14
Heroin Dependence 14
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Condition MeSH

Condition MeSH for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Intervention Trials
Opioid-Related Disorders 47
Substance-Related Disorders 17
Heroin Dependence 15
Disease 11
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Clinical Trial Locations for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Trials by Country

Trials by Country for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Location Trials
United States 190
Canada 7
Norway 6
Taiwan 3
China 2
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Trials by US State

Trials by US State for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Location Trials
New York 21
California 18
Maryland 17
Florida 11
Utah 9
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Clinical Trial Progress for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Clinical Trial Phase Trials
Phase 4 28
Phase 3 17
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Clinical Trial Phase Trials
Completed 59
Not yet recruiting 26
Recruiting 13
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Clinical Trial Sponsors for Buprenorphine Hydrochloride; Naloxone Hydrochloride

Sponsor Name

Sponsor Name for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 39
Indivior Inc. 12
New York State Psychiatric Institute 7
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Sponsor Type

Sponsor Type for Buprenorphine Hydrochloride; Naloxone Hydrochloride
Sponsor Trials
Other 112
NIH 41
Industry 38
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