Thursday, November 21, 2024 11/21/2024

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

Award Number: R33AT009932
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT 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 two 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 R21 portion are to solidify partnerships with proposed clinical program sites in order to develop a plan for implementing the study intervention and procedures, and to finalize study related documents necessary for the R33, including: study protocols, data collection and informed consent forms, intervention manuals and fidelity assessment checklists, training plans for research staff, data safety and monitoring plans. The first aim for the R33 portion is to evaluate the effectiveness of MABT + MAT compared to MAT only (treatment-as-usual) in reducing opioid use (primary outcome), opioid craving, MAT discontinuation, and non-opioid drug use (secondary outcomes) at the six-month time point. Aim 2 will examine the effectiveness of MABT + MAT for improving mental health distress (i.e. depression, anxiety, somatization, emotion regulation difficulties) compared to MAT only at 6 months. Aim 3 will explore the effectiveness of MABT + MAT compared to MAT only in reducing co-morbid pain severity and interference (Brief Pain Inventory) and pain sensitivity (cold pressor test). 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = -$260,440 )
2025	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	4	10/1/2024	NON-COMPETING CONTINUATION	-$260,440
														Subtotal = -$260,440

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	4	5/28/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	4	5/19/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	4	6/29/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $613,713 )
2021	2021	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	4	5/28/2021	NON-COMPETING CONTINUATION	$613,713
														Subtotal = $613,713

Issue Date FY: 2020 ( Subtotal = $738,950 )
2020	2020	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	3	5/22/2020	NON-COMPETING CONTINUATION	$738,950
														Subtotal = $738,950

Issue Date FY: 2019 ( Subtotal = $827,236 )
2019	2019	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	000	2	5/28/2019	EXTENSION WITH OR WITHOUT FUNDS	$755,822
2019	2019	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	002	2	9/20/2019	EXTENSION WITH OR WITHOUT FUNDS	$0
2019	2019	UNIVERSITY OF WASHINGTON	4333 BROOKLYN AVE NE	SEATTLE	WA	98195	KING	USA	Research and Training in Complementary and Integrative Health	001	2	9/6/2019	EXTENSION WITH OR WITHOUT FUNDS	$71,414
														Subtotal = $827,236

Grand Total All Awards = $1,919,459

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

Award Number: R33AT009932

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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