NCT00879996

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2009

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

April 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 13, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
9 months until next milestone

Results Posted

Study results publicly available

July 9, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

2.5 years

First QC Date

April 10, 2009

Results QC Date

March 21, 2012

Last Update Submit

August 3, 2012

Conditions

Opiate Addiction

Keywords

Opiate AddictionNarcotic AddictionDrug AddictionPain

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Retained in Treatment

    This outcome assesses the number of participants who completed the treatment after 6 months.

    6 months

Secondary Outcomes (3)

  • Numerical Rating Score for Pain

    6 months

  • Numerical Rating Score for Functioning

    6 months

  • Self-reported Illicit Opioid Use

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

Drug: Methadone

2

EXPERIMENTAL

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

Interventions

MethadoneDRUG

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

Also known as: Dolophine
1
Buprenorphine/naloxoneDRUG

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

Also known as: Suboxone
2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sheehan Memorial Hospital

Buffalo, New York, 14203, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

Related Publications (2)

  • 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.

    PMID: 36063082DERIVED

  • 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.

    PMID: 23480249DERIVED

MeSH Terms

Conditions

Opioid-Related DisordersNarcotic-Related DisordersSubstance-Related DisordersPain

Interventions

MethadoneBuprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic ChemicalsBuprenorphineMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsNaloxoneHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Limitations and Caveats

small subject number not a double-blind study

Results Point of Contact

Title
Dr. Richard Blondell
Organization
SUNY Buffalo
blondell@buffalo.edu
716-898-4971

Study Officials

  • Richard D Blondell, MD

    SUNY Buffalo

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 10, 2009

First Posted

April 13, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

August 7, 2012

Results First Posted

July 9, 2012

Record last verified: 2012-08

Locations

US(2)