Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial

NCT05571917 | Active Not Recruiting DMC

• 2 other identifiers: 2206006784RM1DA055301
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Interference

  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).

  Change from baseline through 12-month follow-up period

Secondary Outcomes (6)

• Change in Pain Intensity

  Change from baseline through 12-month follow-up period

• Change in Depression

  Change from baseline through 12-month follow-up period

• Change in Pain-Related Anxiety

  Change from baseline through 12-month follow-up period

• Change in Pain Acceptance

  Change from baseline through 12-week treatment period and 12-month follow-up period

• Change in Valued-Action

  Change from baseline through 12-week treatment period and 12-month follow-up period

Study Arms (2)

ACT + MBRP Intervention

EXPERIMENTAL

The ACT + MBRP group will follow a manualized clinical protocol. Treatment will include 12 weekly, virtual group-based sessions, each lasting 90 minutes. Group sizes will range from three to ten participants. All sessions will be audio recorded for fidelity. Over the course of the group meetings, participants identify areas of meaningful functioning that have been adversely impacted by pain, learn methods to enhance pain willingness in the service of these meaningful areas, and practice present-focused awareness skills. Group sessions include discussions of the impact of pain and distress avoidance, identifying alternatives to this avoidance and establishing plans for behavior change, demonstration and role-playing exercises, and homework assignments. Participants are provided with a treatment manual to help guide and inform practice outside of group sessions.

Behavioral: Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

The Enhanced Usual Care (EUC) condition will supplement standard practices within the study sites related to chronic pain and OUD education. Participants randomized to the EUC condition will receive a brochure (in-person, via email, or via text message) with a list of chronic pain treatment resources, signs and management of opioid overdose including naloxone, and overdose prevention, and will encouraged to schedule an appointment with a clinical provider if they would like to discuss any current or past symptoms. In addition to receiving the brochure, EUC condition participants will meet with a therapist remotely for approximately 15 minutes for a descriptive overview of the brochure. In this session, the therapist will point out the resources in the brochure and read the helpful tips out loud to the participant. This session will be audio recorded for fidelity.

Behavioral: Enhance Usual Care (EUC)

Interventions

Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP) BEHAVIORAL

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.

ACT + MBRP Intervention

Enhance Usual Care (EUC) BEHAVIORAL

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.

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stabilized on a dose of buprenorphine for a period of at least 1 month. Buprenorphine stabilization will be defined as a consistent dose for at least 30 consecutive days.
• Willing to comply with all study procedures and be available for the duration of the study.
• Aged 18 years or older.
• Enrolled as a patient in one of the participating clinics.
• Presence of chronic pain for \> 6 months in duration.

You may not qualify if:

• Current or past diagnosis of schizophrenia, delusional disorder, psychotic or dissociative disorders.
• Unable to read English.
• Have a substance use disorder requiring a higher level of care than outpatient treatment (e.g., severe alcohol use disorder requiring inpatient detoxification).

Sponsors & Collaborators

• University of New Mexico: lead
• University of Michigan: collaborator
• Wake Forest University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Chronic Pain

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Katie Witkiewitz, PhD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All investigators (Drs. Pearson, Witkiewitz, Hurlocker, Ilgen, and Lin) will be blinded. The research coordinators located within each site will not be blinded, as they will be involved in coordinating participant screening and randomization. Data analysis will be conducted by a study statistician blinded to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Grant Principal Investigator

Model Details: A research coordinator who is not involved in the intervention phases of the study will randomize individuals to study arm. A block randomization method stratified by site and gender will be used with a random block size based on group scheduling, where groups will start with a group size of three to ten participants. The coordinator will generate a randomization list prior to the implementation phase. To further maintain masking, a research assistant who is not involved in the intervention phases of the study will administer all assessment measures.

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: October 7, 2022
• Study Start: May 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the time of publication of the primary manuscript, or within 12 months of last patient procedure
• Access Criteria: Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy

Locations

US (2)