Sunday, November 24, 2024 11/24/2024

Optimization and multi-site feasibility of yoga for chronic pain in people in treatment for opioid use disorder

Award Number: R01AT010863
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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Chronic pain is a significant problem for at least half of all persons receiving opioid agonist therapy (OAT) for opioid use disorder – i.e., buprenorphine/ naloxone (BUP) or methadone maintenance treatment (MMT). Pharmacotherapeutic pain management is challenging in OAT patients, and other behavioral options for managing chronic pain are needed. Hatha yoga may be a useful adjunctive approach for decreasing pain- related disability and pain severity, and preventing opioid misuse during OAT. There is evidence supporting its efficacy in other chronic pain populations, and yoga may target cravings and other risk factors for opioid relapse. With NCCIH R34 funding, we conducted a pilot RCT of a 12-week hatha yoga class vs. a health education class (HE; a control condition) for people with chronic pain receiving MMT (n=20) or BUP (n=20) for opioid use disorder. The primary target of the yoga intervention was decreased life interference due to pain. In this study, we measured multiple indices of feasibility and acceptability of the manualized interventions. Although we met a priori benchmarks on many of these feasibility indices, we did find that, consistent with literature on behavioral interventions in OAT patients, some participants attended only very few classes. Thus, as a next step in this research, the purpose of the current project is to develop an optimized yoga intervention package that includes key components that increase yoga dosage received, defined as time in class (a function of number of classes attended) plus home yoga practice time. We plan to use the Multiphase Optimization STrategy (MOST) to do this. We will evaluate four intervention components, all of which will be added to our standard group yoga classes, to determine their impact on total yoga dosage received. These components are: a) two added 1:1 meetings with the yoga teachers; b) provision of study teacher-led home practice videos; c) monetary incentives for class attendance; and d) text messages designed to increase intrinsic motivation for yoga practice. As a secondary goal, in keeping with the U01 program announcement, we will also demonstrate that we can conduct this research in two sites distinct from each other and from our previous site. In this study, after conducting pilot work (Phase 1), we plan to conduct a fully-powered factorial experiment that will allow us to evaluate the impact of each of the 4 intervention components on yoga dosage received. All participants will receive the core yoga intervention, with random assignment to receive or not receive each of the four intervention components outlined above. Results from Phase 2 will allow us to choose an efficient combination of intervention components that, together with standard yoga classes, maximizes yoga dosage. We will also be able to examine mechanisms by which intervention components are hypothesized to work. This project will prepare us for the next step in this research, i.e., a fully-powered, multi-site RCT testing the optimized yoga intervention (vs. a control condition), with a primary outcome of reduced pain interference.


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: 2024 ( Subtotal = $732,955 )
2024	2024	BUTLER HOSPITAL	345 BLACKSTONE BLVD STE 2	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	000	5	3/18/2024	NON-COMPETING CONTINUATION	$673,123
2024	2024	BUTLER HOSPITAL	345 BLACKSTONE BLVD STE 2	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	001	5	5/15/2024	NON-COMPETING CONTINUATION	$59,832
														Subtotal = $732,955

Issue Date FY: 2023 ( Subtotal = $763,909 )
2023	2023	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	000	4	2/24/2023	NON-COMPETING CONTINUATION	$763,909
														Subtotal = $763,909

Issue Date FY: 2022 ( Subtotal = $810,133 )
2022	2022	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	003	3	3/7/2022	NON-COMPETING CONTINUATION	$695,317
2022	2022	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	005	3	6/9/2022	NON-COMPETING CONTINUATION	$77,258
2022	2022	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	004	3	3/21/2022	SUPPLEMENT FOR EXPANSION	$37,558
2022	2021	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	000	2	11/4/2021	NON-COMPETING CONTINUATION	$0
2022	2021	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	001	2	11/5/2021	SUPPLEMENT FOR EXPANSION	$0
2022	2021	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	002	2	12/8/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $810,133

Issue Date FY: 2021 ( Subtotal = $886,012 )
2021	2021	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	000	2	2/19/2021	NON-COMPETING CONTINUATION	$763,073
2021	2021	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	002	2	8/27/2021	SUPPLEMENT FOR EXPANSION	$0
2021	2021	BUTLER HOSPITAL	345 BLACKSTONE BLVD	PROVIDENCE	RI	02906	PROVIDENCE	USA	Research and Training in Complementary and Integrative Health	001	2	8/25/2021	SUPPLEMENT FOR EXPANSION	$122,939
														Subtotal = $886,012

Grand Total All Awards = $3,193,009

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Optimization and multi-site feasibility of yoga for chronic pain in people in treatment for opioid use disorder

Award Number: R01AT010863

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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