CLINICAL TRIALS PROFILE FOR SUBUTEX
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505(b)(2) Clinical Trials for Subutex
| 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 | >Sponsor | >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| NCT00398008 ↗ | HIV Risk Reduction and Drug Abuse Treatment in Iran | Withdrawn | National Institute on Drug Abuse (NIDA) | Phase 2 | 2004-10-01 | A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance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| NCT00398008 ↗ | HIV Risk Reduction and Drug Abuse Treatment in Iran | Withdrawn | Yale University | Phase 2 | 2004-10-01 | A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined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 | 2008-02-22 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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