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Randomized Controlled Trial
. 2020 Jan-Mar;38(1):33-41.
doi: 10.1080/10550887.2019.1690929. Epub 2019 Nov 27.

Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction

Anne M Neumann  1 , Richard D Blondell  1 , Rachel A Hoopsick  1 , Gregory G Homish  2
Affiliations
Randomized Controlled Trial

Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction

Anne M Neumann et al. J Addict Dis. 2020 Jan-Mar.

Abstract

Opioid analgesic consumption has led to an unprecedented epidemic of overdose death and opioid addiction in the US history. The treatment of chronic pain in patients with opioid addiction who receive prescriptions for opioid medications presents a clinical dilemma. Continuing opioid medication could result in hyperalgesia rendering opioids ineffective and results in iatrogenic therapeutic damage as evidenced by the worsening of addiction. Discontinuing opioid medications could result in severe pain and cravings that often leads the patient to the illicit market. This study compared methadone and buprenorphine/naloxone in patients with failed back surgery syndrome and opioid addiction. Nineteen participants were randomly assigned to methadone or buprenorphine/naloxone and were followed for 6 months. In an intent-to-treat analysis analgesia, craving, functioning, drug use, depression, and treatment retention were assessed monthly. It was planned to enroll 66 patients with failed back surgery syndrome and opioid addiction; however, enrollment was closed early due to suspected abuse of medications. Patients in both treatment conditions exhibited significantly improved 24-hour pain severity with up to 20% reduction of pain severity at the last follow-up (p < .05). However, patients receiving methadone reported significantly reduced current pain severity, whereas patients receiving buprenorphine/naloxone did not. Patients reported significantly improved functioning, fewer cravings, less opioid use, and depression (p < .05) across the treatment conditions. When given a choice between methadone and buprenorphine/naloxone, buprenorphine/naloxone is recommended due to its superior safety profile. Treatment with either needs to be monitored closely.

Trial registration: ClinicalTrials.gov NCT01559454.

Keywords: Methadone; buprenorphine; chronic pain; failed back surgery syndrome; opioid addiction.

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Conflict of interest statement

There are no conflicts of interest to report.

Figures

Figure 1:
Figure 1:
Participant flow chart
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