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Buprenorphine and Methadone for Opioid Dependent Chronic Pain Patients

NCT ID: NCT00879996

Last Updated: 2012-08-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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).

Conditions

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Opiate Addiction

Keywords

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Opiate Addiction Narcotic Addiction Drug Addiction Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

Methadone

Intervention Type DRUG

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

2

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

Group Type EXPERIMENTAL

Buprenorphine/naloxone

Intervention Type DRUG

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

Interventions

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Methadone

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

Intervention Type DRUG

Buprenorphine/naloxone

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

Intervention Type DRUG

Other Intervention Names

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Dolophine Suboxone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

State University of New York at Buffalo

OTHER

Sponsor Role lead

Responsible Party

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Richard Blondell

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard D Blondell, MD

Role: PRINCIPAL_INVESTIGATOR

SUNY Buffalo

Locations

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Sheehan Memorial Hospital

Buffalo, New York, United States

Site Status

Erie County Medical Center

Buffalo, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36063082 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23480249 (View on PubMed)

Other Identifiers

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K23AA015616

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03DA029768

Identifier Type: NIH

Identifier Source: secondary_id

View Link

FMD0350908A

Identifier Type: -

Identifier Source: org_study_id