Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
CompletedPhase 4NCT01559454
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- A Randomized Controlled Trial Comparing Buprenorphine and Methadone for Treatment in Opioid Dependent Chronic Back Pain Patients
- Conditions
- Interventions
- Drug: Methadone
- Drug: Buprenorphine/naloxone
- Sponsor
- State University of New York at Buffalo
- Start date
- 2012-02
- Primary completion
- 2014-05
- Sex
- All
- Age range
- from 18 Years to 65 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01559454