Methadone in Neuropathic Pain

January 26, 2021 updated by: Mary Lynch, Nova Scotia Health Authority

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • QEII Health Science Centre Pain Management Unit
    • Ontario
      • London, Ontario, Canada, N6A4L6
        • St. Joseph's Health Care Centre, Neuropathic Pain Clinic
    • Quebec
      • Montreal, Quebec, Canada, H3G1A4
        • Alan Edwards Pain Management Unit, McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than18 years
  • Chronic neuropathic pain of central or peripheral origin for 3 months or longer as determined by the study physician and a score of 4/10 or greater on the DN4
  • Moderate to severe pain as defined by average 7-day pain score of greater than 4 on an 11-point numerical rating scale for pain intensity (NRS-PI).
  • Physician has identified that an opioid is a valid adjunctive treatment for the chronic neuropathic pain.
  • Concomitant non-opioid analgesic medications must have been stable for 14 days.
  • Co-interventions such as TENS, acupuncture and massage must have been stable for 14 days prior to the trial
  • If taking an opioid, maximum dose of opioid in oral morphine equivalents (OME) is 90 mg/24 hours.
  • Ability to follow the protocol with reference to cognitive and situational conditions; e.g., stable housing, able to attend follow-up visits.
  • Willing and able to give written informed consent.

Exclusion Criteria:

  • Patients on a dose of opioid that exceeds 90 mg/24 hours in OME
  • Pregnant or lactating women (women of childbearing potential must have negative pregnancy test)
  • History of psychosis
  • History of (within the past 2 years) , or current, substance dependency disorder
  • Excluded medications are listed in Appendix 1.
  • Presence of clinically significant cardiac or pulmonary disorder on physical exam that would compromise participants' safety in the trial as judged by the study physician.
  • Presence of significant conduction delay, ischemia or arrhythmia on screening ECG
  • Presence of severe pain disorder other than the chronic neuropathic pain under study that would interfere with patient's ability to determine effect of study treatment on the chronic neuropathic pain
  • Abnormalities above 1.5 times upper range of normal on screening CBC, blood chemistry including BUN, Cr, LDH, AST, ALT
  • Patients with a history of allergy to any opioid.
  • Participation in another clinical trial in the 30 days prior to enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Methadone
Drug: Methadone
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).
Active Comparator: Controlled Release Morphine
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
controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
to determine if methadone is an effective opioid for the treatment of chronic neuropathic pain
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Collaborators

Canadian Institutes of Health Research (CIHR)
Dalhousie University
Nova Scotia Health Research Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 17, 2010

First Posted (Estimate)

September 20, 2010

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDHA-RS/2010-Meth

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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