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Examining a Digital Perinatal Smoking-Cessation Intervention

Award Number: UG3DA065232
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 05/15/2026
PERIOD OF PERFORMANCE END DATE: 04/30/2028

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Examining a Digital Perinatal Smoking-Cessation Intervention - PROJECT SUMMARY Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S., contributing to serious adverse events ranging from catastrophic pregnancy outcomes to later-in-life metabolic syndrome. Perinatal smoking has a disproportionate adverse impact on populations with constrained access to healthcare (e.g., rural residents). We developed a clinic-based financial-incentives (FI) intervention for perinatal smoking cessation that has been shown to be efficacious and cost-effective in randomized controlled trials (RCTs) and meta-analyses. Indeed, in 2024 the United Kingdom announced national implementation of clinic-based FI for perinatal smoking delivered by National Health Service tobacco interventionists. Unfortunately, scaling clinic- based versions in the U.S. is difficult as many prenatal-care clinics and hospitals fail to provide smoking- cessation services, especially in rural regions where many obstetrical services or entire hospitals are closing. Hence, we developed a digital FI intervention in collaboration with DynamiCare Health Inc. In a Phase 2 RCT that we conducted with 90 pregnant participants recruited across 33 U.S. states, adding this digital FI intervention to best practices (BP+FI) increased odds of cessation 4-fold above BP alone. Maximum FI earnings possible in that trial were $1,620 across the approximately 9-month intervention, with a mean [SD] incentive payout of $331 [446] per women treated. This smartphone-based digital FI intervention previously received Food and Drug Administration (FDA) Breakthrough Device Designation. We are submitting this UG3/UH3 application to conduct Phase 2 (UG3) and Phase 3 (UH3) RCTs in collaboration with FDA with the overarching aim of having this digital FI intervention authorized as an FDA Approved Digital Therapeutic. The UG3 Phase 2 RCT will address a January 2025 Substance Abuse and Mental Health Services Administration advisory that caps maximum potential earnings in FI for treating substance use disorders at $750 when using federal funds. Because federal funds will be essential to successful U.S. implementation of this digital FI intervention, we propose to conduct a UG3 Phase 2 RCT (N=137) examining the efficacy of BP+FI with $750 maximum earnings versus BP alone. Based on prior FI RCTs and meta-analyses, we hypothesize that BP+FI will remain efficacious with a $750 maximum although with a smaller effect size than at the $1,620 value which is why we are proposing a larger sample size in the UG3 than our prior Phase 2 RCT. Go/no-go criteria for the UG3 phase are: (1) complete an FDA Q-submission and (2) the UG3 trial results support the efficacy of BP+FI at $750 maximum earnings for increasing antepartum smoking abstinence significantly above BP alone. If these benchmarks are met , we propose to conduct a UH3 effectiveness trial (N to be informed by UG3 results and FDA recommendations) examining overall smoking abstinence, birth outcomes, treatment acceptability, and cost-effectiveness. Overall, this digital FI intervention has potential to bring sorely needed and effective perinatal smoking-cessation services to U.S. women including rural residents and others with constrained access to healthcare.


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 = $732,462 )
2026	2026	UNIVERSITY OF VERMONT & STATE AGRICULTURAL COLLEGE	85 S PROSPECT STREET	BURLINGTON	VT	05405	CHITTENDEN	USA	Drug Use and Addiction Research Programs	000	1	5/5/2026	NEW	$732,462
														Subtotal = $732,462

Grand Total All Awards = $732,462

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Examining a Digital Perinatal Smoking-Cessation Intervention

Award Number: UG3DA065232

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 05/15/2026

PERIOD OF PERFORMANCE END DATE: 04/30/2028

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