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Mindful Body Awareness With Buprenorphine for Opioid Use Disorder Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04082637
Recruitment Status : Recruiting
First Posted : September 9, 2019
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Cynthia Price, University of Washington

Brief Summary:
The national opioid epidemic requires development of real-world evidence-based treatments for opioid use disorder, including adjuncts to Medication Assisted Treatment (MAT) with buprenorphine. 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 MAT in three clinical settings funded 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. Each setting employs a variation of the nationally recognized Massachusetts Nurse Care Manager model. Using a randomized, two-group, repeated measures design, we will compare those who receive MABT+ MAT to MAT only. The overarching goal of this application is to test MABT to improve MAT health outcomes among patients receiving buprenorphine to treat OUD. The specific aims for the combined R33/R01 clinical protocol are to: 1) evaluate the effectiveness of MABT + TAU compared to TAU only in reducing opioid use (OU) and other illicit 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 with OUD engaged in buprenorphine treatment will be recruited for participation at one of three 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 MAT with buprenorphine and directly impact the future direction of the Washington Opioid STR program.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Behavioral: Mindful Awareness in Body-oriented Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Mindful Body Awareness Training as an Adjunct to Medication Assisted Treatment for Opioid Use Disorder
Actual Study Start Date : August 14, 2019
Estimated Primary Completion Date : July 2, 2023
Estimated Study Completion Date : August 2, 2023

Arm Intervention/treatment
Experimental: MABT* + Medication Assisted Treatment
Mindful Awareness in Body-oriented Therapy + Medication-assisted Treatment
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.
Other Name: MABT

No Intervention: Treatment as Usual



Primary Outcome Measures :
  1. Time Line Follow-back [ Time Frame: 90 days ]
    Patient-reported days of opioid use and other substances



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosed with opioid use disorder
  • enrolled in a Nurse Care Manager buprenorphine treatment program
  • is stable in program, involving at least 4 weeks of treatment (to assure medication initiation/induction has occurred) and Rx appointments are less frequent than once/week
  • 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 MAT 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04082637


Contacts
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Contact: Cynthia Price, PhD 1-206-685-4739 cynthiap@uw.edu
Contact: Joseph Merrill, MD joem@uw.edu

Locations
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United States, Washington
Harborview Hospital Recruiting
Seattle, Washington, United States, 98104
Contact: Joseph Merrill, MD       joem@uw.edu   
Sponsors and Collaborators
University of Washington
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Cynthia Price, PhD University of Washington
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Responsible Party: Cynthia Price, Research Professor, University of Washington
ClinicalTrials.gov Identifier: NCT04082637    
Other Study ID Numbers: STUDY00005923
R33AT009932 ( U.S. NIH Grant/Contract )
R21AT009932 ( U.S. NIH Grant/Contract )
R01AT010742 ( U.S. NIH Grant/Contract )
First Posted: September 9, 2019    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cynthia Price, University of Washington:
Buprenorphine
Medication-assisted treatment
Mind-body therapies
Mindfulness
Interoception
Mindful Awareness in Body-oriented Therapy
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders