Buprenorphine Substitution as a Tapering Strategy for Opioid Discontinuation in Patients with Chronic Pain: A Nonrandomized and Proof of Concept Study.

Introduction: Long-term use (≥ 3 months) of opioids for chronic noncancer pain (CNCP) shows limited benefit and often leads to dependence, especially when tapered too quickly. Standard opioid discontinuation typically involves gradual dose reduction, yet many patients fail to complete it. Meta-analyses show buprenorphine reduces withdrawal severity, increases treatment retention and completion rates, and facilitates analgesia and smoother transitions in patients with chronic pain, with low adverse effects and high initiation success.

Methods: This single-center, prospective, nonrandomized proof-of-concept study assessed the efficacy of an outpatient buprenorphine-based discontinuation strategy in patients with CNCP and opioid dependence who had failed standard tapering. Participants first attempted gradual tapering; those unsuccessful transitioned to buprenorphine: 4-8 mg/day for 1 month, followed by tapering over up to 9 months. Success was defined as complete opioid cessation at 9 months, confirmed by urine analysis (including buprenorphine). The primary outcome was the success rate of the buprenorphine strategy, with ≥ 60% considered effective. A secondary outcome compared success rates between strategies.

Results: Of 20 patients, six (30.0%) successfully withdrew using standard tapering. Fourteen failed; 11 of them transitioned to buprenorphine. Of these, seven (63.6%) achieved full discontinuation. While not statistically significant, the buprenorphine group showed a higher success rate than standard tapering (p = 0.076; OR = 4.08 [0.90-21.23]).

Conclusions: Buprenorphine substitution appears at least as effective as conventional tapering and may benefit patients unable to succeed with tapering alone. These preliminary results support further investigation in larger trials.

Trial registration: ClinicalTrials. gov identifier, NCT03156907.