Clinical trial NCT05571917: Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Official title: Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Chronic Pain
Lead sponsor: University of New Mexico
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Wake Forest University
name: National Institute on Drug Abuse (NIDA)
First posted: 2022-10-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Pain Interference
timeFrame: Change from baseline through 12-month follow-up period
Secondary outcomes:
measure: Change in Pain Intensity
timeFrame: Change from baseline through 12-month follow-up period
measure: Change in Depression
timeFrame: Change from baseline through 12-month follow-up period
measure: Change in Pain-Related Anxiety
timeFrame: Change from baseline through 12-month follow-up period
measure: Change in Pain Acceptance
timeFrame: Change from baseline through 12-week treatment period and 12-month follow-up period
measure: Change in Valued-Action
timeFrame: Change from baseline through 12-week treatment period and 12-month follow-up period
measure: Change in Craving
timeFrame: Change from baseline through 12-week treatment period and 12-month follow-up period
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Katie Witkiewitz, PhD
role: PRINCIPAL_INVESTIGATOR
References: