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Last Updated: December 6, 2019

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CLINICAL TRIALS PROFILE FOR METHADONE HYDROCHLORIDE

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505(b)(2) Clinical Trials for Methadone 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New Formulation NCT00505583 Study Evaluating Oral MOA-728 in Subjects on Methadone Therapy Withdrawn Valeant Pharmaceuticals International, Inc. Phase 1 2007-07-01 To evaluate the effects of single oral doses of MOA-728 compared to a positive control in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.
OTC NCT02929589 Ibuprofen to Decrease Opioid Use and Post-operative Pain Following Unilateral Inguinal Herniorrhaphy Not yet recruiting Mike O'Callaghan Federal Hospital N/A 2017-04-01 This is a prospective, randomized, double-blinded, and placebo-controlled trial comparing oxycodone/acetaminophen prescribed with or without ibuprofen for pain control following open unilateral inguinal hernia repair, with allowed exception of any currently prescribed opioid (codeine, hydrocodone, hydromorphone, morphine, methadone, oxymorphone, transdermal fentanyl), which can be continued. The patients will not be allowed to continue any over-the-counter pain medications, such as ibuprofen, naproxen, or acetaminophen containing medications, that were not prescribed by the investigators during this study. Patients not receiving Ibuprofen will be given a placebo pill composed of corn starch. The placebo pill will be formulated into the same shape, size and color as the ibuprofen capsule. Neither the investigators nor the research subjects will know if the subject is receiving a placebo versus Ibuprofen. The subjects will complete pain level and medication diaries, and will be followed for 2 months after their surgery. The research aims to discover the appropriate amount of opioid medication to prescribe to patients undergoing an elective open inguinal hernia repair, and reduce the total opioid dose needed by utilizing ibuprofen in combination. The investigators expect that the subjects who take ibuprofen will use less oxycodone/acetaminophen, and have comparable or lower mean pain levels. This could contribute to reducing the surplus opioids prescribed by physicians after surgery, which can lead to opioid use disorders. This particular procedure is common in men, and the findings have the potential to decrease the symptoms and pain of Active Duty members and DoD beneficiaries who undergo an inguinal hernia repair, and are at risk for prescription drug abuse or dependence.
>Trial Type >Trial ID >Title >Status >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 >Phase >Start Date >Summary

Clinical Trial Conditions for Methadone Hydrochloride

Condition Name

Condition Name for Methadone Hydrochloride
Intervention Trials
Opioid-Related Disorders 35
Opioid Dependence 30
Pain 30
HIV Infections 15
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Condition MeSH

Condition MeSH for Methadone Hydrochloride
Intervention Trials
Opioid-Related Disorders 64
Substance-Related Disorders 31
Cocaine-Related Disorders 27
Pain, Postoperative 25
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Clinical Trial Locations for Methadone Hydrochloride

Trials by Country

Trials by Country for Methadone Hydrochloride
Location Trials
United States 291
Canada 30
Brazil 8
Norway 8
Germany 7
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Trials by US State

Trials by US State for Methadone Hydrochloride
Location Trials
New York 38
Maryland 31
California 26
Connecticut 18
Illinois 18
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Clinical Trial Progress for Methadone Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Methadone Hydrochloride
Clinical Trial Phase Trials
Phase 4 67
Phase 3 46
Phase 2/Phase 3 9
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Clinical Trial Status

Clinical Trial Status for Methadone Hydrochloride
Clinical Trial Phase Trials
Completed 155
Recruiting 55
Unknown status 30
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Clinical Trial Sponsors for Methadone Hydrochloride

Sponsor Name

Sponsor Name for Methadone Hydrochloride
Sponsor Trials
National Institute on Drug Abuse (NIDA) 78
Yale University 22
Johns Hopkins University 16
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Sponsor Type

Sponsor Type for Methadone Hydrochloride
Sponsor Trials
Other 342
NIH 103
Industry 57
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