Adjunctive Mindfulness During Opioid Tapering for Patients with Chronic Low Back Pain: A Study Protocol of a Pilot Randomized Control Trial

Within the past two decades, the prescription of opioids to treat chronic pain has significantly increased. Although opioids are effective for treating acute pain, the long-term effects of chronic opioid use have not been completely specified. Mindfulness practice has been shown to impact pain intensity and hyperalgesia as well as mental health symptoms and substance dependence. The purpose of this study is to examine the effects of Mindfulness Oriented Recovery Enhancement (MORE) on pain outcomes, opioid use patterns, and anxious and depressive symptoms in individuals with chronic low back pain (CLBP). A total of 60 participants with CLBP who plan to begin tapering the use of their prescription opioid medication will be enrolled. Participants will be randomized (in a 1:1 ratio) into a MORE intervention group or a psychoeducation group. All participants will meet weekly virtually for 8 weeks. At baseline, post-treatment, and 6-month follow-up, the primary study outcomes of pain, endogenous pain modulation function, prescription opioid dose and opioid misuse will be measured, as well as secondary study outcomes of anxiety and depressive symptoms and potential demographic moderators. Participant changes in pain, opioid use, affect and mindful attention will be compared at baseline, post-treatment, and 6-month follow-up time points using a repeated measures ANOVA. The outcomes of this study may provide support for the effectiveness of adjunctive mindfulness interventions in reducing chronic pain, opioid use and mental health symptoms.