Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP): This intervention is an integrated psychosocial treatment of two established treatments for chronic pain and Opioid Use Disorder (OUD). This intervention focuses on reducing pain interference and preventing relapse to opioid misuse.

Enhance Usual Care (EUC): This intervention consists of psychoeducational materials about chronic pain treatment resources, signs and management of opioid overdose and overdose prevention. This intervention also consists of a brief, remote visit with a study therapist, lasting approximately 15 minutes.

Study summary

This study is a multisite randomized clinical trial of a treatment designed to reduce pain interference while simultaneously addressing relapse prevention among individuals who have co-occurring chronic pain and Opioid Use Disorder (OUD). This study will recruit approximately 160 individuals who are currently being treated in clinics specializing in the physician management of OUD. To increase generalizability of study findings and increase internal validity of the physician management component of treatment, all participants will be stabilized on buprenorphine for OUD as part of their usual clinical care. Individuals will be randomized to either: (1) enhanced usual care or (2) the integrated ACT + MBRP treatment. The investigators hypothesize that: (1) the combination of ACT + MBRP in buprenorphine-prescribed patients with chronic pain will be more efficacious across primary and secondary outcome measures in comparison to Enhanced Usual Care and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.

Eligibility

Primary outcome measure(s)

• Change in Pain Interference — Change from baseline through 12-month follow-up period
  Pain interference between participants randomized to ACT+MBRP vs EUC assessed by Pain interference will be measured via Patient Reported Outcome Measurement Information System (PROMIS) Bank v1.0 Pain Interference: The National Institutes of Health (NIH) PROMIS toolkit measure for pain interference. Each item ranges from 0 (not at all) to 5 (very much interfered) and higher scores reflect more severe pain interference. This questionnaire asks about pain interference in the past 7 days (collected once at baseline, post-treatment, and months 6 and 12).

Trial sites (2)

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