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Assessing the real-world impact of a low nicotine product standard for smoked tobacco in New Zealand

Award Number: R01DA058264
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2028

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Assessing the real-world impact of a low nicotine product standard for smoked tobacco in New Zealand - A low nicotine product standard for cigarettes and other combusted tobacco products has been proposed as a cornerstone of the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation in the United States (US). This proposed standard is based largely on randomized clinical trials demonstrating that when people switch to very low nicotine content (VLNC) cigarettes, cigarettes per day, dependence and biomarkers of smoke exposure decrease and quit attempts and cessation increase. Yet, these trials have important limitations. Notably, they limit the duration of exposure to VLNC cigarettes; cannot recreate the complex context of real-world product standards; are characterized by the use of non-study, normal nicotine cigarettes; and generally focus on samples of convenience. The Smokefree 2025 Action Plan outlines a strategy to reduce smoking prevalence to less than 5%. A major component of the initiative is to mandate a low nicotine product standard for all smoked tobacco. Our primary research objective is to assess impact of a mandated reduction of nicotine in all smoked tobacco products. We propose to conduct a longitudinal, mixed methods cohort study of adults who smoke daily or nearly daily (N=1500), using online surveys, biomarkers of exposure, physiological assessments, qualitative interviews, and medical records to assess changes in smoking behavior, health and well-being. We will follow the cohort for 3.5 years (1.5 years before and 1 year after implementation of a low nicotine product standard). We will also explore potential differences by explicitly sampling individuals with self-reported anxiety and depression, adults with low educational attainment, and heavy alcohol and/or cannabis use. We will also enroll people who smoke but do not have these characteristics. The primary outcome for Aim 1 is abstinence from smoked tobacco (self-reported and biochemically-verified) at 52 weeks after policy implementation. The primary outcome for Aim 2 is Health-Related Quality of Life ratings at 52 weeks after policy implementation. Aim 3 will explore potential differences in response to a low nicotine products standard. As a team, we have complementary areas of expertise (e.g., behavioral pharmacology, public health and medicine, biostatistics, epidemiology, qualitative and mixed methods) to ensure the successful completion of the current proposal.


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 = $609,798 )
2026	2026	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	004	4	9/17/2026	SUPPLEMENT FOR EXPANSION	$193,987
2026	2026	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	4	9/17/2026	SUPPLEMENT FOR EXPANSION	$6,934
2026	2026	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	4	9/17/2026	SUPPLEMENT FOR EXPANSION	$20,226
2026	2026	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	4	9/11/2026	NON-COMPETING CONTINUATION	$388,651
2026	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	3	2/16/2026	NON-COMPETING CONTINUATION	$0
														Subtotal = $609,798

Issue Date FY: 2025 ( Subtotal = $673,052 )
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	003	3	9/18/2025	SUPPLEMENT FOR EXPANSION	$19,830
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	004	3	9/18/2025	SUPPLEMENT FOR EXPANSION	$6,799
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	005	3	9/18/2025	SUPPLEMENT FOR EXPANSION	$226,642
2025	2025	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	002	3	9/16/2025	NON-COMPETING CONTINUATION	$419,781
2025	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	2	1/15/2025	NON-COMPETING CONTINUATION	$0
2025	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	2	3/27/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $673,052

Issue Date FY: 2024 ( Subtotal = $618,835 )
2024	2024	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	001	2	8/30/2024	NON-COMPETING CONTINUATION	$618,835
2024	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	10/16/2023	NEW	$0
														Subtotal = $618,835

Issue Date FY: 2023 ( Subtotal = $720,154 )
2023	2023	WAKE FOREST UNIVERSITY HEALTH SCIENCES	MEDICAL CENTER BLVD	WINSTON SALEM	NC	27157	FORSYTH	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	8/31/2023	NEW	$720,154
														Subtotal = $720,154

Grand Total All Awards = $2,621,839

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Assessing the real-world impact of a low nicotine product standard for smoked tobacco in New Zealand

Award Number: R01DA058264

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 09/01/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2028

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