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Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

Award Number: R33AT010125
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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Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment - Opioid Use Disorder (OUD) is a national health crisis. Office-Based Opioid Treatment (OBOT) with buprenorphine/naloxone (B/N) prevents overdose deaths. Psychosocial stress and psychiatric problems (e.g., Anxiety) are major reasons for OBOT drop out and relapse. Many patients turn to benzodiazepines (BZD) to address anxiety and emotional distress with dangerous consequences. Nonpharmacologic approaches to anxiety, stress, and emotion dysregulation are needed during primary care OBOT, which is the primary access point for OUD treatment in most US counties. Mindfulness-Based Interventions (MBI) safely and reliably reduce the impact of stress, anxiety, depression, and chronic pain, which could increase OBOT retention, while reducing rates of relapse and overdose deaths. However, current 8-week standard MBIs do not appear to have strong, sustained impact on substance use outcomes, suggesting longer or enhanced MBIs are needed in the OUD treatment setting. This project originally proposed to adapt, refine, and compare the effectiveness of the 6-month live-online Mindful Recovery OUD Care Continuum (M-ROCC) versus a standard recovery group in primary care. M-ROCC is derived from the evidence-based, established Mindfulness Training for Primary Care (MTPC) program, which has been adapted for Opioid Use Disorder. M-ROCC includes a flexible, patient-centered, motivationally responsive design, including a Low Dose Mindfulness Entry Group, Mindfulness Maintenance Check-in Support Group, and an intensive Mindfulness Training for Primary Care (MTPC-OUD) Group. M-ROCC builds on the previously demonstrated ascending mindfulness practice dose ladder approach, which helps individuals with OUD nurture motivation and resolve ambivalence for mindfulness practice. MTPC has been shown to lower anxiety, stress, and depression, while increasing self-efficacy and capacity for behavioral change by engaging self-regulation mechanisms. During the R21 phase, we established the feasibility and acceptability of the M-ROCC program and prepared for the R33 phase by training providers and obtaining necessary approvals and site contracts. In the R33 phase, we planned to conduct a five-site RCT comparing M-ROCC versus Group-Based Opioid Treatment (GBOT). Due to the COVID-19 pandemic, we modified all aspects of the R33 phase to be conducted with a national sample in a remote, live-online, virtual format, comparing M-ROCC versus a standard online recovery group for 196 patients prescribed B/N for OUD, primarily evaluating its impact on opioid use and anxiety. We all evaluate effects on cocaine and BZD use, as well as aspects of self-regulation needed for sustained addiction recovery. Participants in the online clinical trial are recruited from multiple U.S. states through provider outreach and social media advertising.


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 = -$141,808 )
2025	2022	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	10/1/2024	SUPPLEMENT FOR EXPANSION	-$135,834
2025	2022	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	3/13/2025	SUPPLEMENT FOR EXPANSION	-$5,974
														Subtotal = -$141,808

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	9/7/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	9/6/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	9/5/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $700,000 )
2022	2022	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	003	3	9/15/2022	SUPPLEMENT FOR EXPANSION	$700,000
2022	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	7/5/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	9/14/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	9/14/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $700,000

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	11/17/2020	SUPPLEMENT FOR EXPANSION	$0
2021	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	2/8/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	3	12/23/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2020 ( Subtotal = $1,560,720 )
2020	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	3	9/3/2020	NON-COMPETING CONTINUATION	$808,010
2020	2020	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	002	3	9/21/2020	SUPPLEMENT FOR EXPANSION	$696,691
2020	2019	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	001	2	9/8/2020	EXTENSION WITH OR WITHOUT FUNDS	$56,019
														Subtotal = $1,560,720

Issue Date FY: 2019 ( Subtotal = $819,993 )
2019	2019	CAMBRIDGE PUBLIC HEALTH COMMISSION	1493 CAMBRIDGE ST	CAMBRIDGE	MA	02139	MIDDLESEX	USA	Research and Training in Complementary and Integrative Health	000	2	9/20/2019	EXTENSION WITH OR WITHOUT FUNDS	$819,993
														Subtotal = $819,993

Grand Total All Awards = $2,938,905

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Effect of Mindfulness Training on Opioid Use and Anxiety During Primary Care Buprenorphine Treatment

Award Number: R33AT010125

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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