Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Baxter
Moodys
Mallinckrodt
Express Scripts
AstraZeneca
Medtronic

Last Updated: May 19, 2022

CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard

505(b)(2) Clinical Trials for Buprenorphine Hydrochloride And 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 And 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NCT00000326 ↗ Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1997-04-01 The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone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 Withdrawn 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.
NCT00000327 ↗ Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1997-06-01 The purpose of this study is to compare the clinical efficacy of daily vs. 3-day (MWF) buprenorphine/naloxone combination tablet administration and determine whether outcomes are improved when using a 3-day schedule in which all doses are ingested at the clinic vs. one in which take-home doses are given on intervening days.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Buprenorphine Hydrochloride And Naloxone Hydrochloride

Condition Name

Condition Name for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Intervention Trials
Opioid-Related Disorders 30
Opioid Dependence 19
Opioid-use Disorder 16
Opioid Use Disorder 15
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Intervention Trials
Opioid-Related Disorders 95
Substance-Related Disorders 21
Disease 15
Heroin Dependence 15
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Buprenorphine Hydrochloride And Naloxone Hydrochloride

Trials by Country

Trials by Country for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Location Trials
United States 230
Canada 8
Norway 6
Australia 4
Taiwan 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Location Trials
New York 26
Maryland 21
California 19
Florida 12
Pennsylvania 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Buprenorphine Hydrochloride And Naloxone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Clinical Trial Phase Trials
Phase 4 32
Phase 3 19
Phase 2/Phase 3 4
[disabled in preview] 36
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Clinical Trial Phase Trials
Completed 74
Recruiting 14
Not yet recruiting 13
[disabled in preview] 20
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Buprenorphine Hydrochloride And Naloxone Hydrochloride

Sponsor Name

Sponsor Name for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 44
Indivior Inc. 13
University of California, Los Angeles 9
[disabled in preview] 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Buprenorphine Hydrochloride And Naloxone Hydrochloride
Sponsor Trials
Other 131
Industry 48
NIH 46
[disabled in preview] 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
AstraZeneca
Baxter
Johnson and Johnson
Merck
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.