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Research and Mentoring in Innovative Patient Oriented Pain and Opioid Science

Award Number: K24DA053564
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP
PERIOD OF PERFORMANCE START DATE: 05/01/2021
PERIOD OF PERFORMANCE END DATE: 04/30/2031

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Research and Mentoring in Innovative Patient Oriented Pain and Opioid Science - PROJECT SUMMARY This K24 award will support the candidate as a patient-oriented research mentor and investigator in pain and opioid science. Multiple high-quality datasets involving more than 3,000 participants from her federally funded randomized clinical trials will be leveraged to conduct hypothesis-driven secondary analyses that were beyond the scope of the original trials, thus capitalizing on existing investments for new knowledge. Secondary analyses will center on a new research direction characterizing High-Impact Chronic Pain (HICP), a national research priority, and will include traditional and advance analytics (i.e., machine learning approaches) applied to mentee-led projects. Below is the prime example for proposed secondary analyses in a national comparative effectiveness non- inferiority pain treatment trial (N=1,650) that is comparing two evidence-based behavioral pain treatments (online 1-session Empowered Relief vs. online 8-session cognitive behavioral therapy, CBT) at 3 and 6 months post-treatment. The candidate and her team will characterize long-term comparative effectiveness and heterogeneity of treatment effects for HICP vs. Lower-Impact Chronic Pain (LICP). The following proposed specific aims are outside the scope of any funded work. Specific Aim 1 -- Effectiveness and non-inferiority at 1 year: Determine the long-term (1-year) effectiveness of each treatment, and whether 1-session Empowered Relief (ER) is non-inferior to eight-session CBT on multi-primary pain outcomes (pain intensity and pain interference): H1a: ER and CBT will show baseline to 1 year reductions in pain intensity or pain interference. H1b: ER pain intensity or interference reductions will be non-inferior to CBT (non-inferiority margin = 4.5 T-score points). Specific Aim 2 -- Subgroup analysis: HICP vs. LICP: Characterize treatment outcomes between patients with HICP (baseline Pain Interference >65) and those with LICP (Pain Interference < 65). H2a: ER and CBT will show baseline to 1-year reductions in pain intensity or interference in HICP and LICP, with greater reductions for HICP due to their higher baseline impairment, thus more room to improve. H2b: ER will be non- inferior to CBT for reducing pain intensity or interference in HICP and LICP. Exploratory Aim 3 -- ML-based predictors of response: We will iteratively test established machine learning classifiers (e.g. random forests, support vector machines, and neural networks) to explore 1-year primary and secondary outcomes (sleep, depression, pain catastrophizing) to identify additional patterns and predictors of treatment response in patients with HICP and LICP. The candidate will complete coursework and readings in machine learning, will implement an informatics advisory committee comprised of local statistical and data science collaborators, and will gain further training in implementation science and research rigor and reproducibility to support enhanced mentoring capacity.


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 = $210,735 )
2026	2026	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	6	4/28/2026	COMPETING CONTINUATION	$210,735
														Subtotal = $210,735

Issue Date FY: 2025 ( Subtotal = $207,857 )
2025	2025	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	5	4/14/2025	NON-COMPETING CONTINUATION	$207,857
														Subtotal = $207,857

Issue Date FY: 2024 ( Subtotal = $192,471 )
2024	2024	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	4	4/19/2024	NON-COMPETING CONTINUATION	$192,471
														Subtotal = $192,471

Issue Date FY: 2023 ( Subtotal = $122,826 )
2023	2023	THE LELAND STANFORD JUNIOR UNIVERSITY	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	3	3/29/2023	NON-COMPETING CONTINUATION	$122,826
														Subtotal = $122,826

Issue Date FY: 2022 ( Subtotal = $122,826 )
2022	2022	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	001	2	4/8/2022	NON-COMPETING CONTINUATION	$122,826
2022	2021	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	1	11/15/2021	NEW	$0
														Subtotal = $122,826

Issue Date FY: 2021 ( Subtotal = $191,652 )
2021	2021	LELAND STANFORD JUNIOR UNIVERSITY, THE	450 JANE STANFORD WAY	STANFORD	CA	94305	SANTA CLARA	USA	Drug Use and Addiction Research Programs	000	1	4/23/2021	NEW	$191,652
														Subtotal = $191,652

Grand Total All Awards = $1,048,367

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Research and Mentoring in Innovative Patient Oriented Pain and Opioid Science

Award Number: K24DA053564

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: TRAINING/TRAINEESHIP

PERIOD OF PERFORMANCE START DATE: 05/01/2021

PERIOD OF PERFORMANCE END DATE: 04/30/2031

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