Status:
TERMINATED
Methadone in Neuropathic Pain
Lead Sponsor:
Nova Scotia Health Authority
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Conditions:
Chronic Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01205516
Start Date
January 1 2013
End Date
December 1 2017
Last Update
January 28 2021
Active Locations (3)
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1
QEII Health Science Centre Pain Management Unit
Halifax, Nova Scotia, Canada, B3H 2Y9
2
St. Joseph's Health Care Centre, Neuropathic Pain Clinic
London, Ontario, Canada, N6A4L6
3
Alan Edwards Pain Management Unit, McGill University Health Centre
Montreal, Quebec, Canada, H3G1A4