Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
Utilizing a double-blind, placebo-controlled design, the proposed work will evaluate the ability of an adjuvant anticonvulsant analgesic to diminish or reverse the opioid-induced hyperalgesia complicating the pain states suffered by Methadone-Maintained (MM) patients. Specifically, in a sample of MM patients, gabapentin, which has proven efficacy in treating neuropathic pain will be evaluated for its ability to ameliorate or diminish the opioid-induced hyperalgesia in these patients as reflected by changes on pain threshold and tolerance to both cold-pressor and electrical pain, at peak and through methadone blood levels. The results of this work will not only provide pharmacologic insight into the mechanisms underlying poor pain tolerance in this at-risk population, but also direction for the medical management of pain complicated by opioid-induced hyperalgesia.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?|
- Change in Pain Threshold Time From Baseline to Week 5 [ Time Frame: baseline, 5 weeks ] [ Designated as safety issue: No ]Change in pain threshold time from baseline (pre-gabapentin) to week 5 (post gabapentin)measured during cold pressor task administered at peak methadone blood levels. Pain threshold time is the amount of time that passes before pain is detected after administration of the cold pressor.
|Study Start Date:||September 2002|
|Study Completion Date:||May 2010|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.
|Placebo Comparator: Placebo||
Placebo titrated over 1 week with established dose taken daily for 5 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01210079
|United States, California|
|UCLA School of Nursing|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Margaret (Peggy) A Compton, RN, PhD||University of California, Los Angeles|