Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
The purpose of this study is to determine if buprenorphine or methadone is better for the treatment of chronic pain among patients who have become addicted to prescription narcotics.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients|
- Number of Participants Retained in Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]This outcome assesses the number of participants who completed the treatment after 6 months.
- Numerical Rating Score for Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.
- Numerical Rating Score for Functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]We assessed functioning measured on a 0-10 point numerical rating scale (NRS)with 0 being the least amount of functioning and 10 the best amount of functioning.
- Self-reported Illicit Opioid Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Study Completion Date:||October 2011|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Oral, 10-60 mg per day, 2-4 times per day, 6 months
Other Name: Dolophine
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
Other Name: Suboxone
The purpose of this randomized clinical trial is to compare methadone with buprenorphine for the treatment of chronic pain among patients who have developed a physical dependence on prescription opiate analgesics that is associated with psychosocial dysfunction (i.e., addiction).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879996
|United States, New York|
|Erie County Medical Center|
|Buffalo, New York, United States, 14215|
|Sheehan Memorial Hospital|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Richard D Blondell, MD||SUNY Buffalo|