Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

This study is currently recruiting participants.

Verified February 2011 by State University of New York at Buffalo

First Received on April 10, 2009. Last Updated on February 4, 2011 History of Changes

Sponsor:	State University of New York at Buffalo
Collaborator:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	State University of New York at Buffalo
ClinicalTrials.gov Identifier:	NCT00879996

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 IV

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:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Methadone Naloxone hydrochloride Naloxone Methadone hydrochloride

U.S. FDA Resources

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

Primary Outcome Measures:

Retention in Treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Self-reported pain control [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Self-reported overall level of function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Illicit drug use [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	April 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	April 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

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

Contacts

Contact: Richard D Blondell, MD	716-898-4971	blondell@buffalo.edu
Contact: Lisham Ashrafioun, MA	716-898-6216	la4@buffalo.edu

Locations

United States, New York
Sheehan Memorial Hospital	Recruiting
Buffalo, New York, United States, 14203
Contact: Richard D Blondell, MD 716-848-2000 blondell@buffalo.edu
Contact: Urmo Jaanimagi 716-848-2304
Principal Investigator: Richard D Blondell, MD
Erie County Medical Center	Recruiting
Buffalo, New York, United States, 14215
Contact: Richard D Blondell, MD 716-898-4995 blondell@buffalo.edu
Contact: Lesham Ashrafioun, MA 716-898-6216 la4@buffalo.edu
Principal Investigator: Richard D Blondell, MD

Sponsors and Collaborators

State University of New York at Buffalo

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Richard D Blondell, MD

SUNY Buffalo

More Information

No publications provided

Responsible Party:	Richard D. Blondell/Professor, SUNY Buffalo
ClinicalTrials.gov Identifier:	NCT00879996 History of Changes
Other Study ID Numbers:	FMD0350908A, K23AA015616
Study First Received:	April 10, 2009
Last Updated:	February 4, 2011
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
Opioid-Related Disorders
Compulsive Behavior
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Buprenorphine
Methadone
Analgesics, Opioid
Naloxone
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012