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CLINICAL TRIALS PROFILE FOR NALOXONE HYDROCHLORIDE
505(b)(2) Clinical Trials for Naloxone Hydrochloride
| 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. |
| New Formulation | NCT02158117 | Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use | Completed | St. Olavs Hospital | Phase 1 | 2014-03-01 | Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken. |
| New Formulation | NCT02158117 | Bioavailability of a New Formulation of Nasal Naloxone for Prehospital Use | Completed | Norwegian University of Science and Technology | Phase 1 | 2014-03-01 | Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, twice the annual death toll from traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. A pilot study in this hospital has shown no significant side effects or adverse reaction. While significant benefits are expected from developing an adequately formulated naloxone nasal spray for pre-hospital use, the risks to participants are minimal. Therefore this preclinical study in healthy volunteers will be undertaken. |
| New Formulation | NCT02307721 | Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use | Completed | St. Olavs Hospital | Phase 1/Phase 2 | 2014-12-01 | Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil. |
| New Formulation | NCT02307721 | Pharmacokinetics and Pharmacodynamics of a New Formulation of Nasal Naloxone for Prehospital Use | Completed | Norwegian University of Science and Technology | Phase 1/Phase 2 | 2014-12-01 | Overdose with potential deadly outcome is a serious problem among opioid abusers, not least in Norway. The annual death toll from overdose is about 250, higher than road traffic accidents. Those who inject heroin or other opioids are considered to have the highest risk for death from overdose. To save lives, immediate treatment with a μ-opioid antidote such as naloxone is required. Usually naloxone is injected into a muscle or a blood vessel. Administration of naloxone via the nose (intranasal) has been suggested as an alternative for use by emergency teams and possibly also bystanders. This is not only an easier way to give naloxone, but would also eliminate the risk for needle stick injuries and blood contamination. In a series of studies on intranasal naloxone at The Norwegian University of Science and Technology, this study explores pharmacokinetics and pharmacodynamics of intranasal and intramuscular naloxone in healthy volunteers under the influence of remifentanil. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Naloxone Hydrochloride
| 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. |
| NCT00000193 | Neurobiology of Opioid Dependence: 2 - 2 | Withdrawn | Yale University | Phase 2 | 1993-01-01 | The purpose of this study is to evaluate the effects of gamma hydroxybutyric on naloxone-precipitated opiate withdrawal. |
| NCT00000194 | Neurobiology of Opioid Dependence: 3 - 3 | Withdrawn | National Institute on Drug Abuse (NIDA) | Phase 2 | 1993-01-01 | The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal. |
| NCT00000194 | Neurobiology of Opioid Dependence: 3 - 3 | Withdrawn | Yale University | Phase 2 | 1993-01-01 | The purpose of this study is to study the effects of cycloserine on naloxone-precipitated opiate withdrawal. |
| 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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