Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Conditions
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Opiate Addiction

Intervention / Treatment
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* Drug: Methadone
* Drug: Buprenorphine/naloxone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Methadone 10-60 mg per day in 2-4 divided doses for 6 months | Drug: Methadone<br>* Oral, 10-60 mg per day, 2-4 times per day, 6 months<br>* Other names: Dolophine;|
| Experimental: 2<br>Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg) | Drug: Buprenorphine/naloxone<br>* Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months<br>* Other names: Suboxone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Retained in Treatment | This outcome assesses the number of participants who completed the treatment after 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Score for Pain | Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible. | 6 months | 
| Numerical Rating Score for Functioning | 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. | 6 months | 
| Self-reported Illicit Opioid Use |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opiate Addiction, Narcotic Addiction, Drug Addiction, Pain