Integrative Treatment for Achieving Holistic Recovery From Comorbid Chronic Pain and Opioid Use Disorder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Opioid Use Disorder
- Sponsor
- University of New Mexico
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Change in Pain Interference
- Status
- Active, not recruiting
- Last Updated
- 6 months ago
Overview
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.
Investigators
Katie A Witkiewitz
Grant Principal Investigator
University of New Mexico
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Change in Pain Interference
Time Frame: 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).
Secondary Outcomes
- Change in Craving(Change from baseline through 12-week treatment period and 12-month follow-up period)
- Change in Depression(Change from baseline through 12-month follow-up period)
- Change in Pain Intensity(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)
- Change in Pain-Related Anxiety(Change from baseline through 12-month follow-up period)