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Advancing patient-centered research using meta-analysis of individual patient data to identify clinically significant trajectories of PTSD/SUD and recovery outcomes

Award Number: R01DA061338
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/01/2025
PERIOD OF PERFORMANCE END DATE: 02/28/2029

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Advancing patient-centered research using meta-analysis of individual patient data to identify clinically significant trajectories of PTSD/SUD and recovery outcomes - PROJECT SUMMARY/ABSTRACT Substance use disorders (SUD) are globally prevalent and costly, and polysubstance use is more common than single-substance use. The public health consequences of SUD are compounded by co-occurring posttraumatic stress disorder (PTSD), with several associated outcomes linked to increased mortality, To date, PTSD/SUD treatment evidence syntheses have been repeatedly criticized for “low quality” evidence due in part to several methodological limitations: study-level predictors do not always mirror individual-level effects, study- level measurement bias cannot be corrected in conventional meta-analytic methods, covariates are not always appropriately managed, and few syntheses estimate comparative effect sizes for distinct PTSD/SUD treatment approaches against common controls. Additionally, SUD and PTSD/SUD treatment outcome research has historically emphasized reduction in substance use and clinical severity, not psychosocial recovery, despite the importance of recovery-oriented outcomes to patients seeking treatment. The current project addresses these limitations of the PTSD/SUD treatment literature by using meta-analysis of individual-patient data (MIPD) combined with Integrative Data Analysis (IDA; to adjust for PTSD and SUD measurement error), propensity score weighting (PSW; to mitigate against confounding that can result when “mixing and matching” treatment arms across multiple trials), and contemporary approaches to quantifying clinically significant change (CSC; instead of mean group differences) to test the comparative efficacy of pharmacological, behavioral, and combination treatments for PTSD/SUD on clinical severity and psychosocial recovery outcomes. Thus, in response to RFA-DA-22-037, we propose three Specific Aims. Aim 1: Conduct new analyses on recovery-focused outcomes to evaluate comparative effects of behavioral, pharmacological, and combination treatments for PTSD/SUD. Aim 2: Expand MIPD/IDA methodologies to individual-level statistical inferences regarding the proportion of patients with clinically significant improvement/deterioration across treatment classes. Aim 3: Update and extend MIPD comparative effectiveness analysis of PTSD severity, SUD/AUD consumption, and recovery outcomes to an expanded 60-trial, 8000+ participant PH dataset. The novel integration of CSC into a patient-centered MIPD will yield results that, instead of comparative effectiveness of treatments on average, will give providers information on optimal patient/treatment matches— through greater precision in the expected probabilities for meaningful improvement or deterioration on PTSD, SUD, and recovery outcomes. If successful, this project will yield a synthesis of evidence in short order for the impact of existing PTSD/SUD treatments on clinical and recovery outcomes.


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 = $794,703 )
2026	2026	RUTGERS, THE STATE UNIVERSITY	3 RUTGERS PLZ	NEW BRUNSWICK	NJ	08901	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	2	2/17/2026	NON-COMPETING CONTINUATION	$794,703
														Subtotal = $794,703

Issue Date FY: 2025 ( Subtotal = $882,816 )
2025	2025	RUTGERS, THE STATE UNIVERSITY	3 RUTGERS PLZ	NEW BRUNSWICK	NJ	08901	MIDDLESEX	USA	Drug Use and Addiction Research Programs	000	1	5/29/2025	NEW	$882,816
														Subtotal = $882,816

Grand Total All Awards = $1,677,519

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Advancing patient-centered research using meta-analysis of individual patient data to identify clinically significant trajectories of PTSD/SUD and recovery outcomes

Award Number: R01DA061338

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 06/01/2025

PERIOD OF PERFORMANCE END DATE: 02/28/2029

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