Opioid Use Disorder (OUD) is a national health crisis. Office-Based Opioid Treatment (OBOT) with
buprenorphine/naloxone (B/N) prevents overdose deaths. Psychosocial stress and psychiatric
problems (e.g., Anxiety) are major reasons for OBOT drop out and relapse. Many patients turn to
benzodiazepines (BZD) to address anxiety and emotional distress with dangerous consequences.
Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during
primary care OBOT, which is the primary access point for OUD treatment in most US counties.
Mindfulness-Based Interventions (MBI) safely and reliably reduce the impact of stress, anxiety,
depression, and chronic pain, which could increase OBOT retention, while reducing rates of relapse
and overdose deaths. However, current 8-week standard MBIs do not appear to have strong,
sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in
the OUD treatment setting. This project originally proposed to adapt, refine, and compare the
effectiveness of the 6-month live-online Mindful Recovery OUD Care Continuum (M-ROCC) versus a
standard recovery group in primary care. M-ROCC is derived from the evidence-based, established
Mindfulness Training for Primary Care (MTPC) program, which has been adapted for Opioid Use
Disorder. M-ROCC includes a flexible, patient-centered, motivationally responsive design, including a
Low Dose Mindfulness Entry Group, Mindfulness Maintenance Check-in Support Group, and an
intensive Mindfulness Training for Primary Care (MTPC-OUD) Group. M-ROCC builds on the
previously demonstrated ascending mindfulness practice dose ladder approach, which helps
individuals with OUD nurture motivation and resolve ambivalence for mindfulness practice. MTPC has
been shown to lower anxiety, stress, and depression, while increasing self-efficacy and capacity for
behavioral change by engaging self-regulation mechanisms. During the R21 phase, we established
the feasibility and acceptability of the M-ROCC program and prepared for the R33 phase by training
providers and obtaining necessary approvals and site contracts. In the R33 phase, we planned to
conduct a five-site RCT comparing M-ROCC versus Group-Based Opioid Treatment (GBOT). Due to
the COVID-19 pandemic, we modified all aspects of the R33 phase to be conducted with a national
sample in a remote, live-online, virtual format, comparing M-ROCC versus a standard online recovery
group for 196 patients prescribed B/N for OUD, primarily evaluating its impact on opioid use and
anxiety. We all evaluate effects on cocaine and BZD use, as well as aspects of self-regulation needed
for sustained addiction recovery. Participants in the online clinical trial are recruited from multiple U.S.
states through provider outreach and social media advertising.
