Mindful Body Awareness With Medication Treatment for Opioid Use Disorder

Overview

The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication for Opioid Use Disorder (MOUD). Interventions are needed that address the complex needs of patients with opioid use disorder, which include substantial mental health co-morbidity and high rates of chronic pain related to the complex interaction of opioid prescribing for pain and opioid use disorder. This study leverages recent federal and state opioid use disorder treatment initiatives as a platform for testing a promising mind-body intervention, Mindful Awareness in Body-oriented Therapy (MABT) as an adjunct to MOUD in multiple clinical settings funded primarily through the Washington Opioid State Targeted Response (STR) program. MABT, a novel mindfulness-based intervention, uniquely addresses aspects of awareness, interoception, and regulation that may be associated with pain, mental health distress, and behavioral control that increase risk of relapse and poor treatment outcomes. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+ MOUD vs. MOUD only. The overarching goal of this application is to test MABT to improve MOUD health outcomes. The specific aims for the combined R33/R01 clinical protocol are to: 1) evaluate the effectiveness of MABT + TAU (MOUD) compared to TAU only in reducing opioid use and other substances; 2) examine the effectiveness of MABT + TAU to improve mental and physical health vs. TAU only; 3) examine the effectiveness of MABT + TAU to positively affect substance use related outcomes of craving and treatment retention vs. TAU only. For the R01, there is an additional aim to explore the effectiveness of additional MABT dose offered at 6 months to those with continued substance use (non-responders) compared to those with continued substance use at 6 months in TAU. A two-group (n = 165/165), randomized controlled repeated measures design will be employed. Three hundred thirty individuals engaged in MOUD will be recruited for participation at outpatient treatment sites. Assessments will be administered at baseline, post-intervention (3 months from baseline), and at 6, 9, and 12 months. Results of this study will inform the evidence base for behavioral treatment adjuncts to MOUD and directly impact the future direction of the Washington Opioid STR program.

Full Title of Study: “Mindful Body Awareness Training as an Adjunct to Medication Treatment for Opioid Use Disorder”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 30, 2024

Interventions

  • Behavioral: Mindful Awareness in Body-oriented Therapy
    • A mind-body intervention designed to teach interoceptive awareness skills for emotion regulation and self-care. Delivered individually in 75 minute sessions once a week for 8 weeks.

Arms, Groups and Cohorts

  • Experimental: MABT* + Medication Treatment
    • Mindful Awareness in Body-oriented Therapy + Medication Treatment
  • No Intervention: Treatment as Usual
    • Treatment as Usual is medication for the treatment of opioid use disorder

Clinical Trial Outcome Measures

Primary Measures

  • Time Line Follow-back
    • Time Frame: 90 days
    • Patient-reported days of opioid use and other substances

Participating in This Clinical Trial

Inclusion Criteria

  • diagnosed with opioid use disorder – enrolled in a medication treatment program for opioid use disorder – is stable in program involving, (if on buprenorphine) Rx appointments less frequent than once/week; (if on methadone) at least 90 days in treatment with a minimum dose of 60mg, no missed dose evaluation appointments in past 30 days, and no more than 3 missed doses in 30 days – willing to forego (non-study) manual (e.g., massage) and/or mind-body therapies (e.g., mindfulness meditation) for 3 months – willing to sign release for access of electronic medical records – fluent in English – able to attend study sessions when offered Exclusion Criteria:

  • unwilling or unable to remain in MT treatment for the duration of the trial (includes planned relocation, pending incarceration, planned surgical procedures, etc.) – over 24 weeks gestation or unknown gestation, if pregnant – reports, or is noted by clinical or study staff as showing, overt psychosis or other conditions such as cognitive impairment

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Washington
  • Collaborator
    • National Center for Complementary and Integrative Health (NCCIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cynthia Price, Research Professor – University of Washington
  • Overall Official(s)
    • Cynthia Price, PhD, Principal Investigator, University of Washington

References

Leyde S, Price CJ, Colgan DD, Pike KC, Tsui JI, Merrill JO. Mental Health Distress Is Associated With Higher Pain Interference in Patients With Opioid Use Disorder Stabilized on Buprenorphine or Methadone. Subst Use Addctn J. 2024 Feb 7:29767342241227402. doi: 10.1177/29767342241227402. Online ahead of print.

Citations Reporting on Results

Price CJ, Merrill JO, McCarty RL, Pike KC, Tsui JI. A pilot study of mindful body awareness training as an adjunct to office-based medication treatment of opioid use disorder. J Subst Abuse Treat. 2020 Jan;108:123-128. doi: 10.1016/j.jsat.2019.05.013. Epub 2019 May 23.

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