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Last Updated: September 24, 2021

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CLINICAL TRIALS PROFILE FOR SUBUTEX

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505(b)(2) Clinical Trials for Subutex

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 Subutex

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."
NCT00398008 ↗ HIV Risk Reduction and Drug Abuse Treatment in Iran Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 2004-10-01 A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
NCT00398008 ↗ HIV Risk Reduction and Drug Abuse Treatment in Iran Withdrawn Yale University Phase 2 2004-10-01 A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
NCT00604188 ↗ A Randomized Acceptability and Safety Study of Suboxone Induction in Heroin Users (P05042)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 4 2008-02-01 The purpose of this study is to assess the acceptability and safety of Suboxone in heroin users as a replacement therapy for opioid dependency by comparing the clinical response of participants who are inducted directly onto Suboxone with that of participants who are inducted first to Subutex and then transferred to Suboxone.
NCT00605033 ↗ A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid- Dependent Subjects (Study P04843)(COMPLETED) Completed Indivior Inc. Phase 4 2008-03-01 Post-marketing commitment to the European Medicines Agency to conduct a prospective, controlled study of the transfer from Subutex to Suboxone.
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.
NCT00684073 ↗ Preference for Subutex® (Buprenorphine) Versus Suboxone® (Buprenorphine/Naloxone) in Opioid Dependent Patients on Subutex® (Study P05094)(COMPLETED) Completed Indivior Inc. Phase 4 2007-07-01 This study is designed to determine if opioid dependent subjects who are already receiving Subutex® prefer the Suboxone® tablet over the Subutex® tablet after switching from Subutex® to Suboxone®. Subjects who are selected to participate in this study will continue their prescribed dose of Subutex® (buprenorphine 2 to 16 mg daily) for the first two days of the study (Day 1 and Day 2) then switch to and receive an equivalent dose of Suboxone® (buprenorphine 2 to 16 mg daily) for the last 3 days of the study (Day 3, Day 4 and Day 5). The Day 5 Visit will be the subject's last study visit. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex®.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Subutex

Condition Name

Condition Name for Subutex
Intervention Trials
Opioid-Related Disorders 9
Drug Abuse 6
Opiate Dependence 6
Depression 5
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Condition MeSH

Condition MeSH for Subutex
Intervention Trials
Opioid-Related Disorders 17
Substance-Related Disorders 13
Disease 7
Neonatal Abstinence Syndrome 6
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Clinical Trial Locations for Subutex

Trials by Country

Trials by Country for Subutex
Location Trials
United States 54
Sweden 2
Austria 2
Czech Republic 1
United Kingdom 1
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Trials by US State

Trials by US State for Subutex
Location Trials
Pennsylvania 5
Maryland 5
Utah 4
California 4
Kentucky 4
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Clinical Trial Progress for Subutex

Clinical Trial Phase

Clinical Trial Phase for Subutex
Clinical Trial Phase Trials
Phase 4 7
Phase 3 9
Phase 2/Phase 3 1
[disabled in preview] 21
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Clinical Trial Status

Clinical Trial Status for Subutex
Clinical Trial Phase Trials
Completed 20
Recruiting 7
Not yet recruiting 6
[disabled in preview] 5
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Clinical Trial Sponsors for Subutex

Sponsor Name

Sponsor Name for Subutex
Sponsor Trials
Indivior Inc. 12
National Institute on Drug Abuse (NIDA) 10
Johns Hopkins University 4
[disabled in preview] 11
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Sponsor Type

Sponsor Type for Subutex
Sponsor Trials
Other 28
Industry 23
NIH 11
[disabled in preview] 2
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