CLINICAL TRIALS PROFILE FOR METHADONE HYDROCHLORIDE
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505(b)(2) Clinical Trials for Methadone Hydrochloride
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| New Formulation | NCT00505583 ↗ | Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy | Withdrawn | Bausch Health Americas, Inc. | Phase 1 | 2007-07-01 | To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy. |
| New Formulation | NCT00505583 ↗ | Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy | Withdrawn | Valeant Pharmaceuticals International, Inc. | Phase 1 | 2007-07-01 | To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy. |
| New Formulation | NCT00640159 ↗ | Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease | Completed | Baylor College of Medicine | Phase 4 | 2007-01-01 | Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo. |
| New Indication | NCT01189214 ↗ | Psychopharmacotherapy in Multiple Substances Abuse | Completed | National Institutes of Health (NIH) | Phase 3 | 2009-03-01 | Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence. |
| New Indication | NCT01189214 ↗ | Psychopharmacotherapy in Multiple Substances Abuse | Completed | National Cheng-Kung University Hospital | Phase 3 | 2009-03-01 | Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, the investigators will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence. |
| 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 | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for Methadone Hydrochloride
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00000200 ↗ | Cocaine Effects in Humans: Physiology and Behavior - 1 | Completed | Columbia University | Phase 2 | 1997-01-01 | The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users. |
| NCT00000200 ↗ | Cocaine Effects in Humans: Physiology and Behavior - 1 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1997-01-01 | The purpose of this study is to compare the effects of buprenorphine or methadone maintenance on cocaine taking and on the physiological and subjective effects of cocaine, including cocaine craving, in opiate-dependent cocaine users. |
| NCT00000205 ↗ | Buprenorphine Maintenance Protocol - 1 | Completed | National Institute on Drug Abuse (NIDA) | Phase 3 | 1990-10-01 | The purpose of this study is to compare the efficacy of buprenorphine versus methadone. |
| NCT00000205 ↗ | Buprenorphine Maintenance Protocol - 1 | Completed | University of California, Los Angeles | Phase 3 | 1990-10-01 | The purpose of this study is to compare the efficacy of buprenorphine versus methadone. |
| NCT00000206 ↗ | Clinical Rescue Protocol - 2 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1991-04-01 | The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response. |
| NCT00000206 ↗ | Clinical Rescue Protocol - 2 | Completed | University of California, Los Angeles | Phase 2 | 1991-04-01 | The purpose of this study is to detect increasing medication dose results in heroin cessation for patients still using, to determine if decreasing medication dose in patients unable to tolerate medication dose increases retention, and to determine if blood levels of methadone or buprenorphine correlate with clinical response. |
| NCT00000208 ↗ | Methadone/Buprenorphine Cross-Over Study - 4 | Completed | National Institute on Drug Abuse (NIDA) | Phase 2 | 1992-02-01 | The purpose of this study is to explore ways to cross patients over from methadone to buprenorphine. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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