Methadone in Neuropathic Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Capital District Health Authority, Canada
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Dalhousie University
Information provided by (Responsible Party):
Mary Lynch, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier:
NCT01205516
First received: September 17, 2010
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Chronic Neuropathic Pain
Drug: Methadone
Drug: Controlled Release Morphine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Capital District Health Authority, Canada:

Primary Outcome Measures:
  • to determine if methadone is an effective opioid for the treatment of chronic neuropathic pain [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: January 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01205516

Contacts
Contact: Mary E Lynch, MD 902-473-6428 mary.lynch@dal.ca
Contact: Myrna Yazer, RN 902-473-7449 myrna.yazer@cdha.nshealth.ca

Locations
Canada, Nova Scotia
QEII Health Science Centre Pain Management Unit Recruiting
Halifax, Nova Scotia, Canada, B3H 2Y9
Contact: Mary Lynch, MD         
Sponsors and Collaborators
Capital District Health Authority, Canada
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Dalhousie University
  More Information

No publications provided

Responsible Party: Mary Lynch, MD FRCPC, Capital District Health Authority, Canada
ClinicalTrials.gov Identifier: NCT01205516     History of Changes
Other Study ID Numbers: CDHA-RS/2010-Meth
Study First Received: September 17, 2010
Last Updated: March 5, 2014
Health Authority: Health Canada: Office of Clinical Trials

Additional relevant MeSH terms:
Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Methadone
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Antitussive Agents
Respiratory System Agents
Narcotics

ClinicalTrials.gov processed this record on July 24, 2014