Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

NCT01559454 | Completed Phase 4 Results DMC

• 1 other identifier: FMD0600908A
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic pain patients are treated with prescription opioids and many exhibit opioid addiction. Currently, there are no evidence-based guidelines to better manage patients with chronic pain and coexistent opioid addiction. This study compares 6-months buprenorphine and methadone treatment in these patients. The investigators hypothesize that both buprenorphine and methadone treatment will reduce pain and addiction behaviors and increase functioning in these patients.

Conditions

Low Back Pain

Keywords

chronic pain; opioid dependence; methadone; buprenorphine; substance use disorder

Outcome Measures

Primary Outcomes (1)

• Analgesia

  Pain severity will be measured using the Visual Analogue Scale (VAS) which has a range of 0-100 with 0 being no pain and 100 being worse possible pain.

  6 months

Secondary Outcomes (5)

• Illicit Drug Use

  6 months

• Cravings

  at 6 months

• Functioning

  at 6 months

• Depression

  at 6 months

• Treatment Retention

  6 months

Study Arms (2)

Methadone

ACTIVE COMPARATOR

10-60 mg/day divided by 2-4 times a day

Drug: Methadone

Buprenorphine/naloxone

EXPERIMENTAL

4-16 mg/day divided by 2-4 times a day

Drug: Buprenorphine/naloxone

Interventions

Methadone DRUG

10-60 mg/day divided by 2-4 times a day for 6 months

Also known as: Dolophine

Methadone

Buprenorphine/naloxone DRUG

4-16 mg/day divided by 2-4 times a day for 6 months

Also known as: Suboxone

Buprenorphine/naloxone

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• have a well-documented chronic pain disorder due to past back surgery,
• have a chronic back pain syndrome,
• have evidence of opioid addiction,
• prior attempt at abstinence-oriented treatment documented by the referring physician,
• be able to understand spoken and written English,
• reside in Erie or Niagara counties,
• have health insurance or other ability to pay for treatment with the approval from patient's primary physician;
• have no prior history of methadone or BUP/NLX maintenance treatment since the last surgery,
• not be a member of a vulnerable population, including prisoners

You may not qualify if:

• homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
• inability to give consent,
• those with major co-occurring psychiatric disorders,
• EKG showing prolonged QT and/or previous cardiac issues,
• are taking a medication that is contraindicated with methadone,
• medically unstable,
• urine positive for cocaine at initial visit,
• pregnant women

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

UB/MD Family Medicine, Inc.

Amherst, New York, 14228, United States

Location

Related Publications (3)

• 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: 23480249 BACKGROUND

• 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: 36063082 DERIVED

• Neumann AM, Blondell RD, Hoopsick RA, Homish GG. Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction. J Addict Dis. 2020 Jan-Mar;38(1):33-41. doi: 10.1080/10550887.2019.1690929. Epub 2019 Nov 27.

  PMID: 31774028 DERIVED

MeSH Terms

Conditions

Low Back Pain; Chronic Pain; Opioid-Related Disorders; Substance-Related Disorders

Interventions

Methadone; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Ketones; Organic Chemicals; Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

Early termination due to human subject concerns

Results Point of Contact

• Title: Dr. Ricahrd Blondell
• Organization: University at Buffalo

blondell@buffalo.edu

716-816-7237

Study Officials

• Rachel A Rizzo, MPH

  University at Buffalo

  STUDY DIRECTOR

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: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: February 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: November 3, 2020
• Results First Posted: February 20, 2017

Record last verified: 2020-10

Locations

US (1)