Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Phase 4

Completed

• Conditions: Opiate Addiction
• Interventions: Drug: Methadone; Drug: Buprenorphine/naloxone

• Registration Number: NCT00879996
• Lead Sponsor: State University of New York at Buffalo

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-10
• Study First Submitted QC: 2009-04-10
• Study First Posted: 2009-04-13
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2012-03-21
• Results First Submitted QC: 2012-06-04
• Results First Posted: 2012-07-09
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• chronic back pain
• opioid addiction
• not successful with abstinence
• at least 18 years old
• able to understand spoken English
• live in Western New York State (Erie or Niagara county)
• have health insurance or ability to pay for health care
• no methadone or buprenorphine treatment within past year
• not member of a vulnerable population (e.g., pregnancy, prisoner)

Exclusion Criteria

• homelessness
• unable to give consent (e.g., dementia, psychosis)
• serious heart or lung disease
• taking a medication that could interact with methadone or buprenorphine
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Methadone	Methadone 10-60 mg per day in 2-4 divided doses for 6 months
2	Buprenorphine/naloxone	Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)

Primary Outcome Measures

Name	Time	Method
Number of Participants Retained in Treatment	6 months	This outcome assesses the number of participants who completed the treatment after 6 months.

Secondary Outcome Measures

Name	Time	Method
Numerical Rating Score for Pain	6 months	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	6 months	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	6 months

Trial Locations

Locations (2)

Sheehan Memorial Hospital; 🇺🇸 Buffalo, New York, United States

Erie County Medical Center; 🇺🇸 Buffalo, New York, United States