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Last Updated: February 3, 2023

CLINICAL TRIALS PROFILE FOR NALOXONE


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505(b)(2) Clinical Trials for Naloxone

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.
OTC NCT02137213 ↗ Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation Completed Academic Health Science Centres Phase 2 2014-08-01 At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.
OTC NCT02137213 ↗ Feasibility Study of Oral Naloxone for Treatment of Methadone-induced Constipation Completed Centre for Addiction and Mental Health Phase 2 2014-08-01 At least 30% of patients receiving methadone maintenance therapy (MMT) are suffering from constipation that often affects effectiveness of MMT and increases its impact on health care system. Existing treatments include several over-the-counter medications which do not target the pathobiological basis of opioid-induced constipation and have limited effectiveness. At the same time well-known medication, naloxone, was already shown to help with constipation in patients receiving methadone for chronic pain, but was never tried in patients receiving methadone for opioid dependence. This study is aimed to try naloxone for treatment of opioid-induced constipation in MMT settings. The investigators will enroll 20 patients receiving MMT and suffering from opioid-induced constipation. The study has a crossover design - all patients will receive one week of their regular methadone doses and one week of their regular methadone doses with naloxone added. Normal saline will be added to methadone-only formulations as placebo. Order of the weeks will be chosen randomly. Both subjects and investigators will be blinded to the study condition (i.e. whether naloxone or normal saline is added to methadone preparation on a given week). Primary hypothesis: Patients receiving combination of oral methadone/naloxone in ratio 50:1 will have less severe symptoms of constipation compared to those receiving methadone only. Secondary hypothesis: Addition of oral naloxone to methadone in a ratio 50:1 will not cause clinically significant opioid withdrawal symptoms.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Naloxone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000192 ↗ Neurobiology of Opioid Dependence: 1 - 1 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000192 ↗ Neurobiology of Opioid Dependence: 1 - 1 Withdrawn Yale University Phase 2 1993-01-01 The purpose of this study is to evaluate the effects of lamotrigine on naloxone-precipitated opiate withdrawal.
NCT00000193 ↗ Neurobiology of Opioid Dependence: 2 - 2 Withdrawn National Institute on Drug Abuse (NIDA) Phase 2 1993-01-01 The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Naloxone

Condition Name

Condition Name for Naloxone
Intervention Trials
Opioid-Related Disorders 40
Pain 29
Opioid Dependence 21
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Condition MeSH

Condition MeSH for Naloxone
Intervention Trials
Opioid-Related Disorders 121
Substance-Related Disorders 32
Disease 20
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Clinical Trial Locations for Naloxone

Trials by Country

Trials by Country for Naloxone
Location Trials
United States 455
Canada 22
China 22
Norway 14
Germany 12
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Trials by US State

Trials by US State for Naloxone
Location Trials
New York 41
Maryland 33
California 32
Massachusetts 21
Texas 18
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Clinical Trial Progress for Naloxone

Clinical Trial Phase

Clinical Trial Phase for Naloxone
Clinical Trial Phase Trials
Phase 4 81
Phase 3 54
Phase 2/Phase 3 11
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Clinical Trial Status

Clinical Trial Status for Naloxone
Clinical Trial Phase Trials
Completed 206
Recruiting 38
Not yet recruiting 35
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Clinical Trial Sponsors for Naloxone

Sponsor Name

Sponsor Name for Naloxone
Sponsor Trials
National Institute on Drug Abuse (NIDA) 64
Indivior Inc. 14
University of Pennsylvania 12
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Sponsor Type

Sponsor Type for Naloxone
Sponsor Trials
Other 332
Industry 121
NIH 77
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