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Completed

NCT Number: NCT00879996

Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

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.

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Key information

Conditions

Opiate Addiction Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Neurologic Manifestations Opioid-Related Disorders Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erie County Medical Center, Buffalo, New York, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methadone

Drug

Oral, 10-60 mg per day, 2-4 times per day, 6 months

Other names: Dolophine

buprenorphine/naloxone

Drug

Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months

Other names: Suboxone

Primary outcomes

  1. 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

  1. Numerical Rating Score for Pain

    Time frame: 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.

  2. Numerical Rating Score for Functioning

    Time frame: 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.

  3. Self-reported Illicit Opioid Use

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 13, 2009
Registry last updated
Aug 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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