Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

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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)

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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