Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial

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.

Conditions

• Opioid Use Disorder
• Chronic Pain

Interventions

BEHAVIORAL

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.

BEHAVIORAL

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.

Sponsors & Collaborators

• University of Michigan

  collaborator OTHER

• Wake Forest University

  collaborator OTHER

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• University of New Mexico

  lead OTHER

Principal Investigators

• Katie Witkiewitz, PhD · University of New Mexico

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-05-05

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations