JMIR Publications

ABSTRACT

Background:

Chronic pain is common among individuals with opioid use disorder (OUD) who are maintained on medications for OUD (MOUD; e.g., buprenorphine or methadone). Chronic pain is associated with worse retention and higher levels of substance use. Treatment of individuals with chronic pain receiving MOUD can be challenging due to increased clinical complexity. Given the acute and growing nature of the opioid crisis, MOUD is increasingly offered in a wide range of settings, where high quality, clinician-delivered empirically validated behavioral treatment for chronic pain may not be available. Therefore, digital treatments that support patient self-management of chronic pain and OUD and have the potential for wider implementation to fill this gap.

Objective:

The aim of this study is to evaluate the efficacy of Integrating the Management of Pain and Addiction via Collaborative Treatment (IMPACT), an interactive digital treatment program with asynchronous coach feedback compared to treatment as usual (TAU) in individuals with chronic pain and OUD receiving MOUD.

Methods:

Adult participants (n=160) receiving MOUD and reporting bothersome/high impact chronic pain will be recruited from outpatient opioid treatment programs in Connecticut and randomized (1:1) to either IMPACT+TAU or TAU only. Participants randomized to IMPACT+TAU will complete an interactive digital treatment that includes 9 modules promoting training in pain and addiction coping skills and a progressive walking program. The program is augmented with a weekly personalized voice message from a trained coach based on daily participant reported pain intensity and interference, craving to use opioids, sleep quality, daily steps, pain self-efficacy, MOUD adherence, and engagement with IMPACT collected via digital surveys. Outcomes will be assessed at 3, 6 and 9 months post-randomization. The primary outcome is MOUD retention at 3 months post-randomization (i.e., post-treatment). Secondary outcomes include pain interference, physical functioning, MOUD adherence, substance use, craving, pain intensity, sleep disturbance, pain catastrophizing, and pain self-efficacy. Semi-structured qualitative interviews with study participants (n = 34) randomized to IMPACT (completers and non-completers) will be conducted to evaluate the usability and quality of the program and its outcomes.

Results:

The study has received IRB approval and began recruitment at one site in July 2022. Recruitment at a second site started in January 2023 with a third and final site anticipated to begin recruitment in December 2023. Data collection is expected to continue through June 2025.

Conclusions:

Establishing efficacy for a digital treatment for addiction and chronic pain that can be integrated into MOUD clinics will provide options for individuals with OUD that reduce barriers to behavioral treatment. Participant feedback on the intervention will inform updates/modifications to improve engagement and efficacy. Clinical Trial: ClinicalTrials.gov NCT05204576; https://clinicaltrials.gov/ct2/show/NCT05204576