EFFECT OF OFFERING BUPRENORPHINE TO IMPROVE PAIN AND REDUCE OPIOIDS AMONG PATIENTS ON HIGHDOSE LONG-TERM OPIOID THERAPY: a PRAGMATIC RANDOMIZED TRIAL

BACKGROUND: Opioid tapering is challenging for patients and providers. Observational studies show promise for switching to the partial opioid agonist buprenorphine as an alternative to tapering. Buprenorphine (BUP) has similar analgesic properties yet is safer than other opioids. The Veterans' Pain Care Organizational Improvement Comparative Effectiveness (VOICE) trial tested interventions to improve pain and reduce opioid use among VA primary care patients with chronic pain on long‐term opioid therapy (LTOT). We examined whether offering the option of BUP, compared with no BUP option, would lead to improved pain and greater opioid dose reduction. METHODS: VOICE was a 12‐month, 10‐site, randomized trial that enrolled VA primary care patients with moderate to severe pain despite LTOT. Participants were randomized to 1 of 2 pain care models; both models involved individualized opioid tapering recommendations. Participants prescribed high‐dose opioids (≥70 mg/day) were additionally randomized to receive/not receive the option to discuss BUP and, if deemed appropriate, to switch to BUP. Masked assessors collected outcomes at 3, 6, 9, and 12 months. The primary outcome was change from baseline to 12 months in the Brief Pain Inventory (BPI: score range 0‐10, higher=worse). The main secondary outcome was opioid dose in milligram morphine equivalents (MME). For MME calculations, BUP was considered to be 0. Primary analyses were intent‐totreat and used repeated measures logistic regression for comparisons of primary outcomes. RESULTS: We randomized 207 to BUP option (n=104) or no BUP option (n=103). Mean age was 60.9 years (SD 10.2), 10.6% were female, and 13.9% were Black. At baseline, the mean BPI was 6.8 (SD 1.5) for the BUP arm and 6.8 (SD 1.6) for the no BUP arm. The baseline opioid daily dose was 157 mg (SD 75) for BUP and 165 mg (SD 88) for no BUP. Of 104 BUP option participants, 28 consented to switch to BUP. Across the 10 study sites, the proportion of patients assigned to the BUP arm who switched to BUP was 0‐64%. At 12 months, the mean BPI score was 6.1 (SD 1.9) in the BUP arm and 6.3 (SD 1.7) in the no BUP arm; mean BPI change did not differ between groups (.62 for BUP vs .49 for no BUP, p=0.67). At 12 months, the mean opioid daily dose was 92 mg (SD 98) in the BUP arm and 105 mg (SD 89) in the no BUP arm; mean opioid dose reduction did not differ between treatment groups (65 mg for BUP vs. 61 mg for no BUP, p=0.55). CONCLUSIONS: Adding the option to switch from full‐agonist opioids to BUP did not improve pain severity nor opioid dose reduction compared with individualized tapering alone. Minimal uptake of BUP at some sites limited ability to detect an effect. Qualitative analyses will explore patients' experiences with the BUP option. To maximize patient‐centeredness, prescribers may consider offering switch to BUP as an alternative to standard opioid tapering.