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Randomized Controlled Trial of a Novel Smoking Cessation Application Tailored to Individuals with Serious Mental Illness.

Award Number: R01DA047301
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2020
PERIOD OF PERFORMANCE END DATE: 12/31/2025

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Randomized Controlled Trial of a Novel Smoking Cessation Application Tailored to Individuals with Serious Mental Illness. - PROJECT SUMMARY/ABSTRACT Tobacco use remains at alarming high rates amongst individuals with serious mental illness, such as schizophrenia spectrum, bipolar, and recurring depressive disorders. Smoking tobacco is the number one preventable cause of death in this population, shortening the lifespan of adults with serious mental illness by 25 years and contributing to $317 billion in healthcare expenditures and indirect loss of earnings and disability benefits. Novel and effective models to deliver wider-reaching smoking cessation interventions to individuals with serious mental illness are highly needed and indicated as a priority for NIH. Mobile apps are a promising method to deliver smoking cessation treatments to people with serious mental illness. Despite numerous apps available to use for people with serious mental illness, our feasibility research has demonstrated that using these apps presents daunting challenges for this population. Based on this work, we developed Learn to Quit, a user-centered smoking cessation app tailored to the needs of individuals with serious mental illness. The app’s main active ingredient is a novel behavioral treatment that has shown promise as a smoking cessation intervention -- Acceptance and Commitment Therapy. The app provides education about the use of nicotine replacement therapy and recommendations from US Clinical Practice Guidelines to ensure alignment with best clinical practices. In a recent pilot randomized controlled trial (R00 DA037276), comparing Learn to Quit versus NCI’s QuitGuide, we demonstrated: (1) high recruitment and retention rates, (2) high levels of user engagement with Learn to Quit, (3) an effective method to conduct a large multi-site randomized controlled trial, and (4) promising cessation outcomes. While this developmental work provides initial evidence of Learn to Quit’s usability, feasibility, and preliminary efficacy, a large scale randomized controlled trial is needed to test its efficacy in a representative sample of patients with serious mental illness. Therefore, the proposed study will: (1) employ a randomized parallel arm design to compare the efficacy of Learn to Quit vs. NCI’s QuitGuide, (2) use rigorous methods to evaluate mediators of app engagement and app efficacy, and (3) examine the cost-effectiveness of Learn to Quit compared to a non-tailored app designed for the general population. The study addresses a serious problem -- high smoking rates among people with serious mental illness -- and proposes to test the efficacy of an easily-accessible smoking cessation intervention, using technology with the potential for high population-level reach.


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: 2025 ( Subtotal = $0 )
2025	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	000	5	3/18/2025	NON-COMPETING CONTINUATION	-$193,966
2025	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Drug Use and Addiction Research Programs	001	6	3/18/2025	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$193,966
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $677,893 )
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Drug Use and Addiction Research Programs	003	6	8/28/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$465,465
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	001	5	4/26/2024	NON-COMPETING CONTINUATION	$64,268
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	002	5	8/28/2024	NON-COMPETING CONTINUATION	-$430,262
2024	2024	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	000	5	12/28/2023	NON-COMPETING CONTINUATION	$578,422
														Subtotal = $677,893

Issue Date FY: 2023 ( Subtotal = $725,467 )
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	002	4	8/24/2023	SUPPLEMENT FOR EXPANSION	$79,887
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	000	4	12/16/2022	NON-COMPETING CONTINUATION	$581,023
2023	2023	DUKE UNIVERSITY	2200 W MAIN ST	DURHAM	NC	27705	DURHAM	USA	Drug Use and Addiction Research Programs	001	4	1/11/2023	NON-COMPETING CONTINUATION	$64,557
														Subtotal = $725,467

Issue Date FY: 2022 ( Subtotal = $657,686 )
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	001	3	3/30/2022	NON-COMPETING CONTINUATION	$65,769
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	002	3	4/5/2022	NON-COMPETING CONTINUATION	$0
2022	2022	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	000	3	12/9/2021	NON-COMPETING CONTINUATION	$591,917
														Subtotal = $657,686

Issue Date FY: 2021 ( Subtotal = $663,069 )
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	001	2	1/6/2021	NON-COMPETING CONTINUATION	$0
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	002	2	2/19/2021	NON-COMPETING CONTINUATION	$66,306
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	003	2	7/30/2021	NON-COMPETING CONTINUATION	$0
2021	2021	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	000	2	12/11/2020	NON-COMPETING CONTINUATION	$596,763
														Subtotal = $663,069

Issue Date FY: 2020 ( Subtotal = $700,137 )
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	001	1	8/3/2020	NEW	$0
2020	2020	DUKE UNIVERSITY	2200 W MAIN ST STE 710	DURHAM	NC	27708	DURHAM	USA	Drug Use and Addiction Research Programs	000	1	3/5/2020	NEW	$700,137
														Subtotal = $700,137

Grand Total All Awards = $3,424,252

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Randomized Controlled Trial of a Novel Smoking Cessation Application Tailored to Individuals with Serious Mental Illness.

Award Number: R01DA047301

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/15/2020

PERIOD OF PERFORMANCE END DATE: 12/31/2025

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