NCT04082637

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2019

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

January 24, 2025

Status Verified

January 1, 2025

Enrollment Period

4.5 years

First QC Date

September 3, 2019

Last Update Submit

January 21, 2025

Conditions

Opioid-use Disorder

Keywords

BuprenorphineMedication-assisted treatmentMind-body therapiesMindfulnessInteroceptionMindful Awareness in Body-oriented Therapy

Outcome Measures

Primary Outcomes (1)

  • Time Line Follow-back

    Patient-reported days of opioid use and other substances

    90 days

Study Arms (2)

MABT* + Medication Treatment

EXPERIMENTAL

Mindful Awareness in Body-oriented Therapy + Medication Treatment

Behavioral: Mindful Awareness in Body-oriented Therapy

Treatment as Usual

NO INTERVENTION

Treatment as Usual is medication for the treatment of opioid use disorder

Interventions

Mindful Awareness in Body-oriented TherapyBEHAVIORAL

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.

Also known as: MABT
MABT* + Medication Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cascade Medical Advantage

Bellingham, Washington, 98225, United States

Location

North Olympic Health Network

Port Angeles, Washington, 98362, United States

Location

Harborview Hospital

Seattle, Washington, 98104, United States

Location

Country Doctors Clinics

Seattle, Washington, 98122, United States

Location

Evergreen Treatment Services

Seattle, Washington, 98134, United States

Location

Related Publications (7)

  • 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.

    PMID: 31174929RESULT

  • 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 Jul;45(3):423-433. doi: 10.1177/29767342241227402. Epub 2024 Feb 7.

    PMID: 38327009RESULT

  • Rodriguez MN, Colgan DD, Leyde S, Pike K, Merrill JO, Price CJ. Trauma exposure across the lifespan among individuals engaged in treatment with medication for opioid use disorder: differences by gender, PTSD status, and chronic pain. Subst Abuse Treat Prev Policy. 2024 May 3;19(1):25. doi: 10.1186/s13011-024-00608-8.

    PMID: 38702783RESULT

  • Price CJ, Pike KC, Treadway A, Palmer JK, Merrill JO. Immediate Effects of Mindful Awareness in Body-Oriented Therapy as an Adjunct to Medication for Opioid Use Disorder. Mindfulness (N Y). 2024 Nov;15(11):2794-2811. doi: 10.1007/s12671-024-02463-x. Epub 2024 Nov 19.

    PMID: 39697819RESULT

  • Price CJ, Pike KC, Merrill JO. Longitudinal effects of interoceptive awareness training as an adjunct to medication treatment for opioid use disorder: A randomized clinical trial of Mindful Awareness in Body-oriented Therapy. Drug Alcohol Depend. 2025 Oct 1;275:112813. doi: 10.1016/j.drugalcdep.2025.112813. Epub 2025 Aug 5.

    PMID: 40784065DERIVED

  • Price CU, Pike KC, Treadway A, Palmer J, Merrill JO. Immediate Effects of Mindful Awareness in Body-oriented Therapy as an Adjunct to Medication for Opioid Use Disorder. Res Sq [Preprint]. 2024 Jul 15:rs.3.rs-4727162. doi: 10.21203/rs.3.rs-4727162/v1.

    PMID: 39070653DERIVED

  • Rodriguez MN, Colgan DD, Leyde S, Pike K, Merrill JO, Price CJ. Trauma Exposure Across the Lifespan among Individuals Engaged in Treatment with Medication for Opioid Use Disorder: Differences by Gender, PTSD Status, and Chronic Pain. Res Sq [Preprint]. 2023 Dec 19:rs.3.rs-3750143. doi: 10.21203/rs.3.rs-3750143/v1.

    PMID: 38196650DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Cynthia Price, PhD

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

September 3, 2019

First Posted

September 9, 2019

Study Start

August 14, 2019

Primary Completion

January 30, 2024

Study Completion

March 1, 2024

Last Updated

January 24, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Please see link below to access shared data, housed with ICPSR

Shared Documents
STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Time Frame
currently available with no time limit
Access Criteria
apply to ICPSR for access
More information

Locations

US(5)