NCT01210079

Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Opioid-Induced Hyperalgesia

Interventions

Type	Name	Description
DRUG	Gabapentin;	Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.
DRUG	Placebo	Placebo titrated over 1 week with established dose taken daily for 5 weeks.

Timeline

• Start date: 2002-09-01
• Primary completion: 2008-03-01
• Completion: 2010-05-01
• First posted: 2010-09-28
• Last updated: 2012-04-06
• Results posted: 2012-04-06

Locations

1 site across 1 country: United States