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Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00879996
Recruitment Status : Completed
First Posted : April 13, 2009
Results First Posted : July 9, 2012
Last Update Posted : August 7, 2012
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Richard Blondell, State University of New York at Buffalo

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Opiate Addiction Drug: Methadone Drug: Buprenorphine/naloxone Phase 4

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Study Start Date : April 2009
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879996


Locations
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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
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Richard D Blondell, MD SUNY Buffalo
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Richard Blondell, MD, State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT00879996    
Other Study ID Numbers: FMD0350908A
K23AA015616 ( U.S. NIH Grant/Contract )
R03DA029768 ( U.S. NIH Grant/Contract )
First Posted: April 13, 2009    Key Record Dates
Results First Posted: July 9, 2012
Last Update Posted: August 7, 2012
Last Verified: August 2012
Keywords provided by Richard Blondell, State University of New York at Buffalo:
Opiate Addiction
Narcotic Addiction
Drug Addiction
Pain
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Behavior, Addictive
Pain
Neurologic Manifestations
Compulsive Behavior
Impulsive Behavior
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Buprenorphine
Methadone
 Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents