Mindfulness-Oriented Recovery Enhancement for Prescription Opioid Misuse in Primary Care: Outcomes from a Full-Scale, Nih-Funded Randomized Clinical Trial

Background: Prescription opioid misuse is a public health threat that is being addressed with heightened urgency at both clinical and policy levels. In primary care settings, where chronic pain is commonly treated with long-term opioid therapy, as many as one-in-four chronic pain patients misuse opioids, evidenced by aberrant drug-related behaviors such as dose escalation or use of opioids to self-medicate negative emotions. However, research on psychosocial risk mitigation strategies for opioid misuse among chronic pain patients is scant. The goal of this NIH R01-funded study was to conduct a full-scale randomized clinical trial (RCT) of Mindfulness-Oriented Recovery Enhancement (MORE), an integrative social work intervention designed to treat comorbid opioid misuse and chronic pain in primary care. We hypothesized that MORE, relative to a supportive group (SG) psychotherapy control, would reduce opioid misuse, chronic pain symptoms, opioid dosing, and psychological distress by 9-month follow-up.

Methods: Over a five-year period, individuals with opioid-treated chronic pain who were misusing opioids (N=260; age=56.8±11.7; 66% female) were randomized to 8 weeks of MORE or a SG delivered by a clinical social worker in several community-based primary care clinics in Utah. Outcomes assessors were blinded to treatment condition. Intervention fidelity was monitored and maintained throughout the trial by reviewing session recordings. Opioid misuse was assessed via self-report and triangulated by the validated Drug Misuse Index that integrates self-report with blinded clinical interview and urine toxicology screen. Intention-to-treat analyses were conducted with generalized linear mixed models with Satterthwaite adjusted degrees of freedom. Path analyses examined treatment mediators via bootstrapping of the indirect effect.

Results: Participants randomized to MORE reported significantly greater decreases in opioid misuse by 9-month follow-up than SG participants [F(1,209.64)=4.88, p=.028] – effects that were corroborated by the Drug Misuse Index [F(1,203.00)=4.23, p=.041]. MORE reduced opioid misuse by 42% by 9-month follow-up, whereas SG reduced opioid misuse by 20%. MORE also reduced opioid dose by 33%, relative to a 15% decrease among the SG [F(1,173.05)=6.48, p=.012]. Further, participants in MORE reported significantly greater decreases in pain severity [F(1,213.56)=8.80, p=.003], pain-related functional impairment [F(1,208.16)=23.48, p<.001], and psychological distress [F(1,200.89)=5.03, p=.026]. Increases in savoring positive emotions significantly mediated the effect of MORE on opioid misuse, whereas increases in mindful reappraisal of pain sensations significantly mediated the effect of MORE on chronic pain severity.

Conclusions and Implications: In this five-year, NIH-funded clinical trial—the largest RCT of MORE to date—MORE led to durable, long-term, clinically significant improvements in an objective measure of opioid misuse, as well as chronic pain, opioid dosing, and distress. By targeting a range of theoretically-consistent therapeutic mechanisms, MORE demonstrated efficacy as a treatment for comorbid chronic pain and prescription opioid misuse. Given this clear demonstration of efficacy, MORE should now be disseminated for implementation by social workers providing integrative behavioral health services at community-based primary care clinics.