TY - JOUR
T1 - Randomized clinical trial comparing buprenorphine/naloxone and methadone for the treatment of patients with failed back surgery syndrome and opioid addiction
AU - Neumann, Anne M.
AU - Blondell, Richard D.
AU - Hoopsick, Rachel A.
AU - Homish, Gregory G.
N1 - Funding Information:
This research was supported by an R03 NIH grant (5R03DA029768) awarded to RDB. The study was registered with the Food and Drug Administration (www.ClinicalTrials.gov) and was given the identifier number NCT01559454. The authors thank Neha Sharma, Thomas Drzymala, Ganon Nathan, Marie-Helene Gosselin, and Urmo Jaanim?gi for data collection, Mohammedreza Azadfard, Lorne Campbell, and Stella King for medical treatment of the patients and Frank Jacobi for resources for data analysis.
Publisher Copyright:
© 2020, © 2020 Taylor & Francis Group, LLC.
PY - 2020/1/2
Y1 - 2020/1/2
N2 - 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.
AB - 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.
KW - buprenorphine
KW - chronic pain
KW - failed back surgery syndrome
KW - Methadone
KW - opioid addiction
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U2 - 10.1080/10550887.2019.1690929
DO - 10.1080/10550887.2019.1690929
M3 - Article
C2 - 31774028
AN - SCOPUS:85075729335
SN - 1055-0887
VL - 38
SP - 33
EP - 41
JO - Journal of Addictive Diseases
JF - Journal of Addictive Diseases
IS - 1
ER -