Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Richard Blondell, State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT00879996
First received: April 10, 2009
Last updated: August 3, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Opiate Addiction
Drug: Methadone
Drug: Buprenorphine/naloxone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Resource links provided by NLM:


Further study details as provided by State University of New York at Buffalo:

Primary Outcome Measures:
  • Number of Participants Retained in Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This outcome assesses the number of participants who completed the treatment after 6 months.


Secondary Outcome Measures:
  • Numerical Rating Score for Pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.

  • Numerical Rating Score for Functioning [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Self-reported Illicit Opioid Use [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: April 2009
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Drug: Methadone
Oral, 10-60 mg per day, 2-4 times per day, 6 months
Other Name: Dolophine
Experimental: 2
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
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
Other Name: Suboxone

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879996

Locations
United States, New York
Sheehan Memorial Hospital
Buffalo, New York, United States, 14203
Erie County Medical Center
Buffalo, New York, United States, 14215
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Principal Investigator: Richard D Blondell, MD SUNY Buffalo
  More Information

No publications provided by State University of New York at Buffalo

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Richard Blondell, MD, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00879996     History of Changes
Other Study ID Numbers: FMD0350908A, K23AA015616, R03DA029768
Study First Received: April 10, 2009
Results First Received: March 21, 2012
Last Updated: August 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
Opiate Addiction
Narcotic Addiction
Drug Addiction
Pain

Additional relevant MeSH terms:
Behavior, Addictive
Chronic Pain
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 18, 2014