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.
Phase:
Phase 4
Details
Lead Sponsor:
Nova Scotia Health Authority
Collaborators:
Canadian Institutes of Health Research (CIHR) Dalhousie University Nova Scotia Health Research Foundation