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Mindful Body Awareness With Medication Treatment for Opioid Use Disorder

Primary Purpose

Opioid-use Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindful Awareness in Body-oriented Therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Opioid-use Disorder focused on measuring Buprenorphine, Medication-assisted treatment, Mind-body therapies, Mindfulness, Interoception, Mindful Awareness in Body-oriented Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cascade Medical Advantage
  • North Olympic Health Network
  • Harborview Hospital
  • Country Doctors Clinics
  • Evergreen Treatment Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MABT* + Medication Treatment

Treatment as Usual

Arm Description

Mindful Awareness in Body-oriented Therapy + Medication Treatment

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

Outcomes

Primary Outcome Measures

Time Line Follow-back
Patient-reported days of opioid use and other substances

Secondary Outcome Measures

Full Information

First Posted
September 3, 2019
Last Updated
August 16, 2023
Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04082637
Brief Title
Mindful Body Awareness With Medication Treatment for Opioid Use Disorder
Official Title
Mindful Body Awareness Training as an Adjunct to Medication Treatment for Opioid Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 14, 2019 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
Buprenorphine, Medication-assisted treatment, Mind-body therapies, Mindfulness, Interoception, Mindful Awareness in Body-oriented Therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MABT* + Medication Treatment
Arm Type
Experimental
Arm Description
Mindful Awareness in Body-oriented Therapy + Medication Treatment
Arm Title
Treatment as Usual
Arm Type
No Intervention
Arm Description
Treatment as Usual is medication for the treatment of opioid use disorder
Intervention Type
Behavioral
Intervention Name(s)
Mindful Awareness in Body-oriented Therapy
Other Intervention Name(s)
MABT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time Line Follow-back
Description
Patient-reported days of opioid use and other substances
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Price, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cascade Medical Advantage
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
North Olympic Health Network
City
Port Angeles
State/Province
Washington
ZIP/Postal Code
98362
Country
United States
Facility Name
Harborview Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Country Doctors Clinics
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Evergreen Treatment Services
City
Seattle
State/Province
Washington
ZIP/Postal Code
98134
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31174929
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. Epub 2019 May 23.
Results Reference
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Mindful Body Awareness With Medication Treatment for Opioid Use Disorder

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