drugset / Trial / NCT01559454

Buprenorphine and Methadone for Opioid-dependent Chronic Back Pain Patients

NCT01559454 ↗

Phase 4 Completed 19 enrolled State University of New York at Buffalo
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2012-02
Primary completion
2014-05
Completion
2014-05

Outcome

Missed primary endpoint

registry analysis (unspecified test); Methadone vs Buprenorphine/Naloxone; p = 0.097; Mean Difference (Final Values) 35.4167 (95% CI -8.7519 to 79.5852) NCT01559454 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Buprenorphine Other / unclassified 4 mg —
Subject Buprenorphine Other / unclassified 16 mg —
Comparator Methadone Other / unclassified 10 mg —
Comparator Methadone Other / unclassified 60 mg —
Background Naloxone Small molecule — —

Indications

No indication recorded.