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Last Updated: May 27, 2022

CLINICAL TRIALS PROFILE FOR SUBOXONE


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505(b)(2) Clinical Trials for Suboxone

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 Suboxone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000320 ↗ Buprenorphine Formulation Comparison: Sublingual Tablet vs. Solution - 1 Completed National Institute on Drug Abuse (NIDA) Phase 1/Phase 2 1997-10-01 The purpose of this study is to compare subject response to liquid vs. tablet formulations, to assess bioequivalency of liquid vs. tablet, to compare subject preference, and to evaluate if dose response curve for tablet is equal to liquid form."
NCT00078117 ↗ Suboxone: (Buprenorphine/Naloxone) Comparison of Two Taper Schedules - 1 Completed University of California, Los Angeles Phase 3 2003-06-01 The purpose of this protocol is to to compare the clinical utility of two dosage tapering regimens in Buprenorphine/Naloxone stabilized subjects for opiate detoxification.
NCT00249574 ↗ Bridging Active Heroin Users to Hepatitis C Treatment Using Buprenorphine - 1 Completed Organization to Achieve Solutions in Substance Abuse (OASIS) N/A 2003-06-01 The purpose of this study is to see whether street-recruited heroin users can be successfully treated for hepatitis C after stabilizing them on buprenorphine.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Suboxone

Condition Name

Condition Name for Suboxone
Intervention Trials
Opioid-Related Disorders 14
Opioid Dependence 14
Opioid-use Disorder 11
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Condition MeSH

Condition MeSH for Suboxone
Intervention Trials
Opioid-Related Disorders 69
Substance-Related Disorders 23
Disease 12
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Clinical Trial Locations for Suboxone

Trials by Country

Trials by Country for Suboxone
Location Trials
United States 238
Canada 8
Norway 5
Taiwan 3
Austria 2
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Trials by US State

Trials by US State for Suboxone
Location Trials
New York 17
California 16
Florida 15
Maryland 14
Massachusetts 12
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Clinical Trial Progress for Suboxone

Clinical Trial Phase

Clinical Trial Phase for Suboxone
Clinical Trial Phase Trials
Phase 4 28
Phase 3 21
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Suboxone
Clinical Trial Phase Trials
Completed 61
Recruiting 14
Not yet recruiting 7
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Clinical Trial Sponsors for Suboxone

Sponsor Name

Sponsor Name for Suboxone
Sponsor Trials
National Institute on Drug Abuse (NIDA) 25
Indivior Inc. 19
Johns Hopkins University 7
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Sponsor Type

Sponsor Type for Suboxone
Sponsor Trials
Other 125
Industry 45
NIH 27
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