Single-arm feasibility and preliminary efficacy national pilot study of Empowered Relief in patients with chronic pain taking methadone or buprenorphine (Preprint)

BACKGROUND Approximately 45% of individuals taking methadone or buprenorphine have chronic pain. These medications are commonly prescribed for chronic pain or Opioid Use Disorder (OUD). To optimize pain management as well as reduce opioid-related symptoms (e.g., craving) and risks (misuse, overdose), there is a critical need for a brief, effective, and accessible pain skills intervention for this population. OBJECTIVE The objective of this single-arm study is to examine the feasibility, and preliminary efficacy of online Empowered Relief (ER), a 1-session pain relief skills class, for individuals with chronic pain taking methadone or buprenorphine for chronic pain or OUD. METHODS A priori feasibility criteria were defined as at least 75% of enrolled participants attending ER class and the mean satisfaction rating of at least 8 on a 0-10 scale. Participants were recruited nationally across the U.S. Out of the 69 enrolled participants, 55 attended the ER class. Self-report measures were collected at baseline, immediately post-class, and at follow-up points of 2 weeks, and months 1-3. Additionally, qualitative interviews were conducted in a small sample (n = 14) to obtain in-depth participant feedback. Among the class attendees, 51 participants (52.9% Female; mean age = 48.6, range: 28 – 71) completed at least one follow-up survey, and their treatment outcomes were analyzed using repeated measures ANOVA, with missing data imputed using linear regression. This analytic sample consisted of 24 taking methadone and 27 taking buprenorphine, and 43.1% endorsed at least ≥ 2 OUD symptoms within the past 12 months, meeting the DSM-5 diagnostic criteria for current OUD. RESULTS Feasibility was achieved with 79.7% attendance and M= 8.6 treatment appraisal and satisfaction ratings. Qualitative feedback demonstrated high acceptability of the class content and delivery, with suggestions for refinements. Repeated-measures ANOVAs and Bonferroni post-hoc tests revealed significant reductions at 1-month post-ER class (primary endpoint) in pain intensity (d = 0.41), pain bothersomeness (d = 0.54), and pain interference (d = 0.61). At 3-month post-ER class, efficacy was maintained for pain bothersomeness (d = 0.44) and pain interference (d = 0.), but not for pain intensity. No significant time effects were observed for pain catastrophizing, sleep disturbance, physical function, fatigue, depression, anxiety, social isolation, and opioid craving. CONCLUSIONS This study is the first to test ER in patients taking methadone or buprenorphine for pain or OUD. Findings showed feasibility, acceptability, and preliminary evidence of treatment efficacy. Participant feedback will inform future study designs. Findings support a randomized trial to fully evaluate the efficacy and scalability of ER in this population. CLINICALTRIAL NCT05057988; https://clinicaltrials.gov/study/NCT05057988 INTERNATIONAL REGISTERED REPORT RR2-10.2196/53784