Back to resultsMethadone in Neuropathic Pain
Primary Purpose
Chronic Neuropathic Pain
Status
Terminated
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Methadone
Controlled Release Morphine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Neuropathic Pain
Eligibility 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.
Sites / Locations
- QEII Health Science Centre Pain Management Unit
- St. Joseph's Health Care Centre, Neuropathic Pain Clinic
- Alan Edwards Pain Management Unit, McGill University Health Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methadone
Controlled Release Morphine
Arm Description
Controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).
Outcomes
Primary Outcome Measures
to determine if methadone is an effective opioid for the treatment of chronic neuropathic pain
Secondary Outcome Measures
Full Information
NCT ID
NCT01205516
First Posted
September 17, 2010
Last Updated
January 26, 2021
Sponsor
Nova Scotia Health Authority
Collaborators
Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation, Dalhousie University
1. Study Identification
Unique Protocol Identification Number
NCT01205516
Brief Title
Methadone in Neuropathic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
Funding agency withdrew funding due to slow recruitment
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nova Scotia Health Authority
Collaborators
Canadian Institutes of Health Research (CIHR), Nova Scotia Health Research Foundation, Dalhousie University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neuropathic Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
Experimental
Arm Title
Controlled Release Morphine
Arm Type
Active Comparator
Arm Description
Controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).
Intervention Type
Drug
Intervention Name(s)
Methadone
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Controlled Release Morphine
Intervention Description
controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).
Primary Outcome Measure Information:
Title
to determine if methadone is an effective opioid for the treatment of chronic neuropathic pain
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
QEII Health Science Centre Pain Management Unit
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
St. Joseph's Health Care Centre, Neuropathic Pain Clinic
City
London
State/Province
Ontario
ZIP/Postal Code
N6A4L6
Country
Canada
Facility Name
Alan Edwards Pain Management Unit, McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
35005408
Citation
Lynch M, Moulin D, Perez J. Methadone vs. morphine SR for treatment of neuropathic pain: A randomized controlled trial and the challenges in recruitment. Can J Pain. 2019 Oct 22;3(1):180-189. doi: 10.1080/24740527.2019.1660575. eCollection 2019.
Results Reference
result
Learn more about this trial
Methadone in Neuropathic Pain
We'll reach out to this number within 24 hrs