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Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

Primary Purpose

Opiate Addiction

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Methadone
Buprenorphine/naloxone
Sponsored by
State University of New York at Buffalo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opiate Addiction focused on measuring Opiate Addiction, Narcotic Addiction, Drug Addiction, Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Sheehan Memorial Hospital
  • Erie County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Participants Retained in Treatment
This outcome assesses the number of participants who completed the treatment after 6 months.

Secondary Outcome Measures

Numerical Rating Score for Pain
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
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

Full Information

First Posted
April 10, 2009
Last Updated
August 3, 2012
Sponsor
State University of New York at Buffalo
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00879996
Brief Title
Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Official Title
A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Addiction
Keywords
Opiate Addiction, Narcotic Addiction, Drug Addiction, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Methadone 10-60 mg per day in 2-4 divided doses for 6 months
Arm Title
2
Arm Type
Experimental
Arm Description
Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
Intervention Type
Drug
Intervention Name(s)
Methadone
Other Intervention Name(s)
Dolophine
Intervention Description
Oral, 10-60 mg per day, 2-4 times per day, 6 months
Intervention Type
Drug
Intervention Name(s)
Buprenorphine/naloxone
Other Intervention Name(s)
Suboxone
Intervention Description
Sub-lingual, 4-16 mg per day, divided 2-4 times/day, 6 months
Primary Outcome Measure Information:
Title
Number of Participants Retained in Treatment
Description
This outcome assesses the number of participants who completed the treatment after 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Numerical Rating Score for Pain
Description
Pain was measured using a 0-10 point numerical rating scale (NRS) with 0 representing no pain and 10 representing worst pain possible.
Time Frame
6 months
Title
Numerical Rating Score for Functioning
Description
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.
Time Frame
6 months
Title
Self-reported Illicit Opioid Use
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Blondell, MD
Organizational Affiliation
SUNY Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheehan Memorial Hospital
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Erie County Medical Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
36063082
Citation
Nielsen S, Tse WC, Larance B. Opioid agonist treatment for people who are dependent on pharmaceutical opioids. Cochrane Database Syst Rev. 2022 Sep 5;9(9):CD011117. doi: 10.1002/14651858.CD011117.pub3.
Results Reference
derived
PubMed Identifier
23480249
Citation
Neumann AM, Blondell RD, Jaanimagi U, Giambrone AK, Homish GG, Lozano JR, Kowalik U, Azadfard M. A preliminary study comparing methadone and buprenorphine in patients with chronic pain and coexistent opioid addiction. J Addict Dis. 2013;32(1):68-78. doi: 10.1080/10550887.2012.759872.
Results Reference
derived

Learn more about this trial

Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

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