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Adapting Web-based CBT to improve adherence and outcome for individuals with opioid use disorder and chronic pain treated with opioid agonists

Award Number: R33AT010619
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2022
PERIOD OF PERFORMANCE END DATE: 02/28/2027

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Adapting Web-based CBT to improve adherence and outcome for individuals with opioid use disorder and chronic pain treated with opioid agonists - Chronic pain is common among individuals treated with opioid agonist therapies (OAT; buprenorphine or methadone) and is associated with poorer opioid use disorder (OUD) outcomes, including higher attrition and higher levels of drug use. Treatment of chronic pain in individuals who are maintained on OAT is complex, as presence of chronic pain is associated with greater frequency of psychiatric disorders as well as sleep problems and other comorbidities that can contribute to poorer outcomes. Given the large number of individuals with chronic pain seeking OAT, standardized, lower-cost, and easily disseminable approaches to treat individuals in OAT who have chronic pain are needed and, if demonstrated to be effective in this population, would have high public health significance. In response to RFA-AT-19-006, we plan to develop and pilot test an integrated, web-based cognitive behavioral approach (R61 phase), and then conduct a randomized clinical trial evaluating its efficacy relative to standard care in a large and diverse sample of individuals with chronic pain treated with buprenorphine or methadone (R33 phase). The new program will retain key components of Dr. Carroll’s computer-based training for cognitive-behavioral therapy (CBT4CBT), including its emphasis on teaching cognitive and behavioral coping skills in an engaging way and focus on the 5 A’s of MAT (Adherence, Attendance, Abstinence, Alternate Activities and Accessing support); it will add components from Dr. Heapy’s COPES (Cooperative Pain Education and Self-Management) intervention (self-management of chronic pain, with IVR monitoring of pain intensity and interference, physical activity, and skills practice) and modify existing CBT4CBT modules to address the complex interplay between pain and drug use in this population, emphasizing the development of generalizable skills. In the R33 phase, we will conduct a randomized clinical trial evaluating CBT4CBT-COPES in a diverse sample 160 of individuals enrolled in agonist treatment (methadone or buprenorphine) who have chronic pain, in a 3-month randomized clinical trial with a 6-month follow-up, comparing it to standard treatment alone. The primary retention outcome will be adherence with agonist treatment; the primary pain outcome will be the PROMIS 6-item Pain Interference Short Form.


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: 2026 ( Subtotal = $0 )
2026	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	000	4	4/1/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	000	4	3/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $889,504 )
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	002	4	5/13/2024	NON-COMPETING CONTINUATION	$88,950
2024	2024	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	000	4	2/8/2024	NON-COMPETING CONTINUATION	$800,554
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	003	4	6/4/2024	NON-COMPETING CONTINUATION	$0
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	001	4	3/18/2024	NON-COMPETING CONTINUATION	$0
2024	2024	YALE UNIV	150 MUNSON ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	004	4	7/19/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $889,504

Issue Date FY: 2023 ( Subtotal = $1,200,391 )
2023	2023	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	001	3	3/31/2023	NON-COMPETING CONTINUATION	$926,254
2023	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	000	2	2/1/2023	EXTENSION WITH OR WITHOUT FUNDS	$274,137
														Subtotal = $1,200,391

Issue Date FY: 2022 ( Subtotal = $970,207 )
2022	2022	YALE UNIVERSITY	105 WALL ST	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Research and Training in Complementary and Integrative Health	000	2	5/20/2022	EXTENSION WITH OR WITHOUT FUNDS	$970,207
														Subtotal = $970,207

Grand Total All Awards = $3,060,102

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Adapting Web-based CBT to improve adherence and outcome for individuals with opioid use disorder and chronic pain treated with opioid agonists

Award Number: R33AT010619

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2022

PERIOD OF PERFORMANCE END DATE: 02/28/2027

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