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Randomized controlled trial comparing nonstimulant-first vs stimulant-first strategies in treating ADHD in adults

Award Number: R01MH146143
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2026
PERIOD OF PERFORMANCE END DATE: 08/31/2031

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Randomized controlled trial comparing nonstimulant-first vs stimulant-first strategies in treating ADHD in adults - Abstract This proposal responds to RFA-MH-26-195, Optimizing Treatment Strategies for Adult Attention-Deficit Hyperactivity Disorder (ADHD). Drug therapies robustly reduce core ADHD symptoms and decrease the risk for adverse outcomes. Stimulants are recommended as the first-line medication treatment by most guidelines; nonstimulants are typically reserved for individuals who fail stimulant treatment or for whom misuse is a clear concern. The overall aim of this proposal is to evaluate the impact of using a nonstimulant-first approach and test if it is a viable option for many adults with ADHD using a novel, real world, 12-week, pragmatic clinical trial comparing two treatment pathways: 1) the usual care approach is the stimulant-first strategy, which begins with stimulant medication; 2) the nonstimulant-first strategy, which begins with a nonstimulant medication. This design will allow us to achieve the following specific aims: Aim 1: Noninferiority. Primary Hypothesis 1: After 12 weeks of treatment, the nonstimulant strategy will be noninferior to the stimulant strategy on our primary outcome. This aim will document response rates to each strategy after 12 weeks of treatment. Primary Hypothesis 2: Acceptability of the nonstimulant-first approach will be noninferior to the stimulant-first approach. Aim 2: Heterogeneity of treatment effects (HTE) by Comorbidity. After 12 weeks, superiority for nonstimulants will be seen for the patients with anxiety and/or depression and superiority of stimulants for those without these comorbidities. Aim 3: Secondary Outcomes. We hypothesize the same pattern of results described in Aims 1 and 2 for secondary outcomes. Aim 4: HTE for potential moderators. Exploratory analyses will assess HTE for sex, age, prior stimulant treatment, and provider type (psychiatry vs. other). Aim 5: Time to Response. Prior work from the PIs suggests that titration time for nonstimulants can be substantially reduced by using response after 2-3 weeks as a proxy for ultimate response [Newcorn, 2009 #19924]. We therefore hypothesize that the nonstimulant strategy will be noninferior to the stimulant strategy as regards the time to determine response. Aim 6: Maintenance of Treatment Effects. We hypothesize noninferiority of effectiveness, acceptability, and tolerability at a six-month follow-up. Aim 7: Target Engagement. We hypothesize that effective nonstimulant treatment will engage neuropsychological (response inhibition; cognitive control) targets consistent with known mechanisms of the disorder.


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 = $839,468 )
2026	2026	THE RESEARCH FOUNDATION FOR THE STATE UNIVERSITY OF NEW YORK	750 E ADAMS ST	SYRACUSE	NY	13210	ONONDAGA	USA	Mental Health Research Grants	000	1	9/10/2026	NEW	$839,468
														Subtotal = $839,468

Grand Total All Awards = $839,468

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Randomized controlled trial comparing nonstimulant-first vs stimulant-first strategies in treating ADHD in adults

Award Number: R01MH146143

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/10/2026

PERIOD OF PERFORMANCE END DATE: 08/31/2031

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