Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

University at Buffalo (UB)

Status and phase: Completed; Phase 4

Conditions: Opiate Addiction

Treatments: Drug: Buprenorphine/naloxone; Drug: Methadone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00879996

FMD0350908A

K23AA015616 (U.S. NIH Grant/Contract)

R03DA029768 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

1

Active Comparator group

Description:

Methadone 10-60 mg per day in 2-4 divided doses for 6 months

Treatment:

Drug: Methadone

2

Experimental group

Description:

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

Treatment:

Drug: Buprenorphine/naloxone