Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

Completed · Phase 4

Conditions studied: Low Back Pain

In brief

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.

Key facts

Study ID

NCT01559454

Run by

State University of New York at Buffalo

People needed

19

Starts

2012-02-01

Expected to finish

2014-05-01

Last updated by the study team

2020-11-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• UB/MD Family Medicine, Inc. — Amherst, New York, United States

Full record on ClinicalTrials.gov

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