Summit program to taper long-term opioid therapy in Veterans: A mixed-methods feasibility study

Abstract: Due to the harms associated with long-term opioid therapy and, often, the lack of benefit, it is guideline concordant to offer patients the opportunity to engage in a supportive, patient-centered taper. However, tapering is challenging for both clinicians and patients, with barriers including lack of resources and tools to support tapering and fear of worsening pain. To address these barriers, we created Summit - a web-based app that uses principles of behavioral therapy to offer patients support during voluntary opioid tapers. The aim of this study was to conduct a nine-month randomized pilot feasibility trial (NCT04746833) to evaluate the feasibility of a full-scale trial of the Summit program, and the acceptability of the program to patients (measured quantitatively and qualitatively). Primary outcomes were feasibility (enrollment rate, program use, retention) and acceptability. We enrolled 44 patients (4.9% enrollment rate) who were randomized to either a single session of motivational interviewing before receiving access to Summit or a control condition (pain monitoring app). While use of the Summit website was low, study retention and intervention acceptability were high in both arms. Approximately one-third of participants reported opioid dose reductions during participation. Qualitative interviews highlighted protocol strengths including biweekly data collection that facilitated increased contact with study staff and, for some, a shift in the way participants thought about opioid use and pain. Difficulties in meeting our recruitment target and low program utilization suggest that the recruitment and enrollment approach need to be modified to more robustly evaluate the Summit program. Perspective: This article reports the results of a pilot study evaluating the feasibility and acceptability of a web-based app designed to support opioid tapering. Retention and acceptability metrics were largely met. However, challenges with recruitment and low program utilization suggest modifications are warranted prior to a fully-powered trial.