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Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

This study is currently recruiting participants.
Verified December 2012 by State University of New York at Buffalo
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01559454
First received: March 19, 2012
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Low Back Pain
 Drug: Methadone
Drug: Buprenorphine/naloxone
 Phase 4

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 Treatment in Opioid Dependent Chronic Back Pain Patients

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Analgesia [ Time Frame: monthly for 6 months ] [ Designated as safety issue: No ]
    Pain interference will be measured using the Brief Pain Inventory (BPI). Pain severity will be measured using the Visual Analogue Scale (VAS).


Secondary Outcome Measures:
  • Illicit drug use [ Time Frame: monthly for 6 months ] [ Designated as safety issue: No ]
    Illicit drug use will be measured by self-report and urine toxicology.

  • Cravings [ Time Frame: monthly for 6 months ] [ Designated as safety issue: No ]
    Cravings will be assessed using the Visual Analogue Scale (VAS)

  • Functioning [ Time Frame: monthly for 6 months ] [ Designated as safety issue: No ]
    Functioning will be assessed using the Roland-Morris Disability Questionnaire and the Visual Analogue Scale (VAS).

  • Depression [ Time Frame: monthly for 6 months ] [ Designated as safety issue: No ]
    Depression will be assessed using the Beck Depression Inventory.

  • Treatment retention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 66
Study Start Date: February 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone
10-60 mg/day divided by 2-4 times a day
 Drug: Methadone
10-60 mg/day divided by 2-4 times a day for 6 months
Other Name: Dolophine
Experimental: Buprenorphine/naloxone
4-16 mg/day divided by 2-4 times a day
 Drug: Buprenorphine/naloxone
4-16 mg/day divided by 2-4 times a day for 6 months
Other Name: Suboxone

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. homeless, or any patient without a "locator" (no means to participate in the follow-up data collection interviews by phone),
  2. inability to give consent,
  3. those with major co-occurring psychiatric disorders,
  4. EKG showing prolonged QT and/or previous cardiac issues,
  5. are taking a medication that is contraindicated with methadone,
  6. medically unstable,
  7. urine positive for cocaine at initial visit,
  8. pregnant women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559454

Contacts
Contact: Richard D Blondell, MD 716-898-4971 blondell@buffalo.edu
Contact: Anne Neumann, PhD 716-898-6216 aneumann@buffalo.edu

Locations
United States, New York
UB/MD Family Medicine, Inc. Recruiting
Amherst, New York, United States, 14228
Contact: Anne Neumann, PhD     716-247-5281 ext 157     aneumann@buffalo.edu    
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Study Director: Anne Neumann, PhD University at Buffalo
  More Information

No publications provided

Responsible Party: State University of New York at Buffalo
ClinicalTrials.gov Identifier: NCT01559454     History of Changes
Other Study ID Numbers: FMD0600908A
Study First Received: March 19, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York at Buffalo:
chronic pain
opioid dependence
methadone
buprenorphine
substance use disorder

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 May 22, 2013