Low Back Pain | Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Low Back Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Low Back Pain
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Methadone10-60 mg/day divided by 2-4 times a day for 6 months
Drug:Buprenorphine/naloxone4-16 mg/day divided by 2-4 times a day for 6 months
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Methadone10-60 mg/day divided by 2-4 times a day
Buprenorphine/naloxone4-16 mg/day divided by 2-4 times a day
Start Date: February 2012
Completed Date: May 2014
Phase: Phase 4
Primary Outcome: Analgesia
Secondary Outcome: Illicit Drug Use
Study sponsors, principal investigator, and references
Principal Investigator: Rachel A Rizzo, MPH
Lead Sponsor: State University of New York at Buffalo
Neumann AM, Blondell RD, Jaanimägi 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.