Phase 4
N=19
Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients
Low Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT01559454 ↗Enrolled (actual)
19
Serious AEs
5.3%
Results posted
Feb 2017
Primary outcome: Primary: Analgesia — 36.3; 71.8 units on a VAS scale — p=0.097
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Methadone (Drug); Buprenorphine/naloxone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- State University of New York at Buffalo
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Analgesia |
36.3; 71.8 | 0.097 |
| SECONDARY Illicit Drug Use |
0; 0; 6; 4 | 1.00 |
| SECONDARY Cravings |
11.7; 27.2 | 0.348 |
| SECONDARY Functioning |
31.7; 71.3 | 0.088 |
| SECONDARY Depression |
17.0; 15.3 | 0.895 |
| SECONDARY Treatment Retention |
6; 4; 3; 6 | 0.6999 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01559454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.