A Phase 4 interventional study of Methadone and Controlled Release Morphine in Chronic Neuropathic Pain, sponsored by Nova Scotia Health Authority. Terminated at 3 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-28.
Sponsored by Nova Scotia Health Authority · Phase 4, Interventional, and Treatment
INTRODUCTION: There is an important need for inexpensive drugs that treat neuropathic pain. Early research suggests that methadone may be a good, inexpensive drug to treat neuropathic pain. Methadone is available in a low cost powder that is easily prepared for different routes of administration. This study will look at the effect and safety of methadone compared to the regular treatment of morphine for the treatment of chronic neuropathic pain.
OBJECTIVES: First the investigators want to determine if methadone is effective and safe for the treatment of neuropathic pain. Since a placebo control group would be unethical, the proposed comparator will consist of the "gold standard" conventional treatment, controlled release morphine. The investigators will compare methadone to controlled-release morphine with regard to how it affects the level of pain and extent of side effects. Next the investigators want to examine safety as well as to determine whether methadone leads to improvements in physical and emotional functioning, and participants' satisfaction with the treatment.
METHODS: A double blind, randomized trial comparing methadone and controlled release morphine is proposed. After 1-week, participants will be randomly assigned to either methadone or controlled release morphine and will gradually build to a dose at which they receive adequate pain relief without unacceptable levels of side effects. This 5-week phase will be followed by a 6-week dose phase and then a 4-week tapering off phase.
Study drug: The study drug is methadone supplied in 2.5 mg tablets. The comparator will consist of controlled release morphine in 10 mg tablets. The dose of each will range from 1-12 tablets taken every 12 hours (dose ranges methadone 5-60 mg/day, controlled release morphine 20-240 mg/day).
Setting: This is a 3-site study involving pain clinics in Halifax, Nova Scotia; London, Ontario; and Calgary, Alberta.
1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.
This study's enrollment of 14 is below the median of 52 across 973 interventional studies indexed under Neuralgia.
Browse Neuralgia studies →Nova Scotia Health Authority is the lead sponsor of 255 studies on the registry; 76 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Methadone
Controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).
Drug: Controlled Release Morphine
Patients in the methadone arm will be supplied with 2.5 mg tablets. The dose will consist of 1-12 tablets taken twice daily, every 12 hours (range 5-60 mg per 24 hours).
controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).
to determine if methadone is an effective opioid for the treatment of chronic neuropathic pain
Time frame: 16 weeks
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nova Scotia Health Authority