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Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
State University of New York at Buffalo
ClinicalTrials.gov Identifier:
NCT01559454
First received: March 19, 2012
Last updated: February 17, 2017
Last verified: January 2016
  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
Intervention Model: Parallel Assignment
Masking: No masking
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:


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

Primary Outcome Measures:
  • Analgesia [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures:
  • Illicit Drug Use [ Time Frame: 6 months ]
    Illicit opioid use will be measured by self-report and confirmed with urine toxicology.

  • Cravings [ Time Frame: at 6 months ]
    Cravings will be assessed using the Visual Analogue Scale (VAS) with 0 being no cravings and 100 being worse possible cravings

  • Functioning [ Time Frame: at 6 months ]
    Functioning will be assessed using the Visual Analogue Scale (VAS) with 0 being "no limits" and 100 being "bedridden."

  • Depression [ Time Frame: at 6 months ]
    Depression will be assessed using the Beck Depression Inventory, a 63 point scale with 0 being "none" and 63 being "severe."

  • Treatment Retention [ Time Frame: 6 months ]
    Number of participants that completed the study protocol


Enrollment: 19
Study Start Date: February 2012
Study Completion Date: May 2014
Primary Completion Date: May 2014 (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   (Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559454

Locations
United States, New York
UB/MD Family Medicine, Inc.
Amherst, New York, United States, 14228
Sponsors and Collaborators
State University of New York at Buffalo
Investigators
Study Director: Rachel A Rizzo, MPH University at Buffalo
  More Information

Publications:
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
Results First Received: January 22, 2016
Last Updated: February 17, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We are preparing a de-identified data set that could be shared.

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
Analgesics, Opioid
Buprenorphine
Methadone
Buprenorphine, Naloxone Drug Combination
Naloxone
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 21, 2017