CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 26 enrolled
Drug / intervention
Gabapentin; +1 moredrug
Likely dose
Gabapentin; 2400mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01210079
NCT01210079Phase 2Completed

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

University of California, Los Angeles·interventional·Posted Sep 28, 2010·Updated Apr 6, 2012

In Brief

A Phase 2 clinical trial evaluating Gabapentin; and Placebo for Opioid-Induced Hyperalgesia. Completed, enrolled 26 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 28, 2010
Enrollment StartSep 1, 2002
Primary CompletionMar 1, 2008
Study CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 15.8 years ago

Interventions

Gabapentin;drug

Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.

Placebodrug

Placebo titrated over 1 week with established dose taken daily for 5 weeks.