#feasibility and Preliminary Efficacy of Empowered Relief in Patients With Chronic Pain Taking Methadone or Buprenorphine: Single-Arm National Pilot Study
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 (eg, craving) and risks (misuse and overdose), there is a critical need for a brief, effective, and accessible pain skills intervention for this population. Objective: This single-arm study aimed 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 the ER class and the mean satisfaction rating of at least 8 on a 0‐10 scale. Participants were recruited nationally across the United States. 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 (27/51, 52.9% female; mean age 48.6, SD 12.2, range 28‐71 years) completed at least one follow-up survey, and treatment outcomes were analyzed using repeated measures ANOVA, with missing data imputed using linear regression. This analytic sample consisted of 24 participants taking methadone and 27 participants taking buprenorphine; 43.1% (22/51) endorsed at least≥2 OUD symptoms within the past 12 months, meeting the ( [Fifth Edition]) diagnostic criteria for current OUD. Results: #feasibility was achieved with 79.7% (55/74) attendance and mean 8.6 (SD 2) ratings of treatment appraisal and satisfaction. Qualitative feedback demonstrated high acceptability of the class content and delivery, with suggestions for refinements. Repeated-measures ANOVAs and FDR-corrected post hoc tests revealed significant reductions at 1 month post-ER class (primary endpoint) in pain intensity (Cohen =0.71), pain bothersomeness (Cohen =0.54), and pain interference (Cohen =0.61). At 3 months post-ER class, efficacy was maintained for pain intensity, pain bothersomeness, and pain interference (Cohen =0.28, 0.44, and 0.48, respectively). 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. These findings support a randomized trial to fully evaluate the efficacy and scalability of ER in this population. Trial Registration: ClinicalTrials.gov NCT05057988; https://clinicaltrials.gov/study/NCT05057988 International Registered Report Identifier (IRRID): RR2-10.2196/53784
