Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?
|ClinicalTrials.gov Identifier: NCT01210079|
Recruitment Status : Completed
First Posted : September 28, 2010
Results First Posted : April 6, 2012
Last Update Posted : April 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Opioid-Induced Hyperalgesia||Drug: Gabapentin; Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Hyperalgesia in Methadone-Maintained Patients: Can it be Treated?|
|Study Start Date :||September 2002|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||May 2010|
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.
- Change in Pain Threshold Time From Baseline to Week 5 [ Time Frame: baseline, 5 weeks ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|