PatientsVille.com LogoPatientsVille.com

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

Study Interventions

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

Study Arms

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

Study Status

Completed

Start Date: February 2012

Completed Date: May 2014

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01559454

Neumann AM, Blondell RD, Jaanim├Ągi 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.

Discuss Methadone