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

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 in an 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.

Complex Persistent Opioid Dependence with Long-term Opioids: a Gray Area That Needs Definition, Better Understanding, Treatment Guidance, and Policy Changes

“…9,11 There is evidence that buprenorphine can provide analgesia for chronic pain 16 including sublingual buprenorphine/naloxone preparations approved for OUD treatment. 11,[17][18][19][20] However, conclusive evidence regarding the effectiveness and safety of sublingual buprenorphine/naloxone for CPOD and chronic pain awaits prospective randomized trials. These trials will also need to determine the effective buprenorphine dose, frequency of dosing, and treatment length for treating CPOD.…”

“…More detailed discussion regarding the current methods of buprenorphine utilization in CPOD is beyond the scope of this article and is provided elsewhere. 11,20 Methadone, an effective OUD treatment, has also been used in clinical situations suggestive of CPOD with reasonable effectiveness, 19,22 but the higher burden of dependence that may worsen pain and elevated opioid risk associated with methadone makes buprenorphine a more appealing choice. 11,19 There is little evidence or clinical experience with naltrexone, another medication used in OUD treatment, but its antagonism of the mu receptor suggests disutility in pain treatment.…”

Beneficial Effects of Opioid Rotation to Buprenorphine/Naloxone on Opioid Misuse, Craving, Mental Health, and Pain Control in Chronic Non-Cancer Pain Patients with Opioid Use Disorder

“…An alternative strategy for these patients might be opioid agonist treatment (OAT) with a long-acting mu-opioid receptor agonist, since long-acting opioids might not only stabilize opioid use, but simultaneously provide pain relief. Indeed, some studies investigated the potential of methadone as an OAT in patients with prescription OUD and CNCP, showing long-lasting improvement in pain control [22][23][24].…”

“…Several studies suggest that buprenorphine has similar equi-analgesic properties as full mu-opioid receptor agonists, like morphine and transdermal fentanyl [26]. Studies on the effectiveness of buprenorphine rotation in patients with CNCP and OUD suggested a positive effect on pain [23,[27][28][29][30][31]. However, these studies had a small sample size [23,31], were retrospective in nature [27,28,30], or participants could self-administer additional oxycodone [29].…”

“…Studies on the effectiveness of buprenorphine rotation in patients with CNCP and OUD suggested a positive effect on pain [23,[27][28][29][30][31]. However, these studies had a small sample size [23,31], were retrospective in nature [27,28,30], or participants could self-administer additional oxycodone [29]. Additionally, buprenorphine has a lower risk of respiratory depression, sedation and overdose [32,33].…”