Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial

University of New Mexico (UNM)

Status: Active, not recruiting

Conditions: Opioid Use Disorder; Chronic Pain

Treatments: Behavioral: Enhance Usual Care (EUC); Behavioral: Acceptance and Commitment Therapy + Mindfulness Based Relapse Prevention (ACT + MBRP)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05571917

RM1DA055301 (U.S. NIH Grant/Contract)

2206006784

Details and patient eligibility

About

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.

Full description

Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for OUD. Despite the alarming increases in opioid misuse and OUD nationally, there are few treatment options available that target both pain-related interference and OUD in an integrated fashion among patients with chronic pain. To date, there are no evidence-based treatment options that aim to minimize pain interference while simultaneously addressing OUD among individuals with medication prescribed for OUD.

The present trial builds upon a pilot study that tested the feasibility of integrating two empirically-supported psychosocial interventions, ACT to reduce pain interference and MBRP to reduce opioid misuse. Following successful integration of the interventions, outcome analyses found that the integrated ACT + MBRP intervention reduced both pain interference and opioid misuse at a 6-month follow-up in comparison to physician management alone.

This study is a multisite randomized clinical trial that 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 primary outcome, pain interference, will be assessed at the end of the active treatment phase and at 6- and 12-month follow-ups. Secondary outcomes will include pain intensity, depression, and pain-related fear, and an exploratory outcome of self-report of substance use with urine testing for confirmation. Treatment mechanism variables, including chronic pain acceptance, engagement in values-based action, and opioid craving will be assessed weekly during the active phase of treatment.

Our overall hypotheses are 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 EUC and (2) examination of treatment mechanism data will indicate treatment-related changes that are consistent with the theoretical models of ACT+MBRP.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Willing to comply with all study procedures and be available for the duration of the study.
3. Aged 18 years or older.
4. Enrolled as a patient in one of the participating clinics.
5. Presence of chronic pain for > 6 months in duration.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

160 participants in 2 patient groups

ACT + MBRP Intervention

Experimental group

Description:

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.

Treatment:

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

Enhanced Usual Care (EUC)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhance Usual Care (EUC)