CLINICAL TRIALS PROFILE FOR BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE

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.

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NCT00000326 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment 1 - 1	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1997-04-01	The purpose of this study is to assess the clinical efficacy of the buprenorphine/naloxone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.
NCT00000327 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment I(2) - 2	Withdrawn	University of Colorado, Denver	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.
NCT00000328 ↗	Buprenorphine/Naloxone Treatment for Opioid Dependence-Experiment III) - 3	Withdrawn	National Institute on Drug Abuse (NIDA)	Phase 2	1997-07-01	The purpose of this study is to compare the clinical efficacy of the buprenorphine/naloxone combination tablet to methadone for opioid maintenance treatment.

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 Use Disorder	21
Opioid Dependence	20
Opioid-use Disorder	16

Condition MeSH

Condition MeSH for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Intervention	Trials
Opioid-Related Disorders	102
Substance-Related Disorders	24
Disease	15
Heroin Dependence	15

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	235
Canada	9
Norway	6
Australia	4
Taiwan	3

Trials by US State

Trials by US State for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Location	Trials
New York	26
Maryland	24
California	19
Florida	12
Pennsylvania	12

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	35
Phase 3	20
Phase 2/Phase 3	4

Clinical Trial Status

Clinical Trial Status for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	75
Recruiting	17
Not yet recruiting	15

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)	45
Indivior Inc.	13
University of California, Los Angeles	9

Sponsor Type

Sponsor Type for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Sponsor	Trials
Other	139
Industry	49
NIH	47