Mindful Body Awareness With Medication Treatment for Opioid Use Disorder

Opioid-use Disorder Clinical Trial

Official title:

Mindful Body Awareness Training as an Adjunct to Medication Treatment for Opioid Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082637
• Other study ID #: STUDY00005923
• Secondary ID: R33AT009932R21AT
• Status: Completed
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: March 1, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	Cascade Medical Advantage	Bellingham	Washington
United States	North Olympic Health Network	Port Angeles	Washington
United States	Country Doctors Clinics	Seattle	Washington
United States	Evergreen Treatment Services	Seattle	Washington
United States	Harborview Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. Epu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time Line Follow-back	Patient-reported days of opioid use and other substances	90 days