A Clinical Trial Comparing Tapering Doses of Buprenorphine With Steady Doses for Chronic Pain and Coexistent Opioid Addiction

Objectives: Effective strategies are needed to manage individuals with chronic noncancer pain and coexistent opioid addiction. This study compared opioid discontinuation and opioid replacement protocols. Methods: We planned to enroll 60 individuals into an open-label trial who had been treated with opioids for chronic noncancer pain, and who also had opioid addiction. Participants were randomly assigned to one of the two 6-month treatment protocols of buprenorphine/naloxone sublingual tablets: (1) tapering doses for opioid weaning or "detoxification" (active comparator group) or (2) steady doses for opioid replacement (experimental group). They were followed up monthly for the study outcomes: completion of the 6-month treatment protocol and self-reported pain control, physical functioning, alcohol consumption, and illicit drug use. Results: Enrollment was terminated after enrolling 12 participants because none of the 6 assigned to receive tapering doses could successfully complete the protocol (5 were given steady doses and 1 was admitted to an inpatient chemical dependency treatment program), whereas of the 6 assigned to receive steady doses, 5 completed the protocol (1 withdrew). This difference between the 2 treatment conditions was significant (P = 0.015). Of the 10 participants who completed the 6-month follow-up, 8 reported improved pain control and physical functioning and 5 used alcohol and/or illicit drugs. Conclusions: We conclude that during 6 months, these participants with chronic pain and coexistent opioid addiction were more likely to adhere to an opioid replacement protocol than an opioid weaning protocol and that opioid replacement therapy with steady doses of buprenorphine/naloxone is associated with improved pain control and physical functioning.