A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Overview
- Phase
- Phase 4
- Intervention
- Methadone
- Conditions
- Opiate Addiction
- Sponsor
- State University of New York at Buffalo
- Enrollment
- 54
- Locations
- 2
- Primary Endpoint
- Number of Participants Retained in Treatment
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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).
Investigators
Richard Blondell
MD
State University of New York at Buffalo
Eligibility Criteria
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
Arms & Interventions
1
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Intervention: Methadone
2
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Intervention: Buprenorphine/naloxone
Outcomes
Primary Outcomes
Number of Participants Retained in Treatment
Time Frame: 6 months
This outcome assesses the number of participants who completed the treatment after 6 months.
Secondary Outcomes
- Numerical Rating Score for Pain(6 months)
- Numerical Rating Score for Functioning(6 months)
- Self-reported Illicit Opioid Use(6 months)