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Assessing whether use of fruit flavored ENDS relates to smoking reductions in people who smoke cigarettes: A data triangulation approach to maximize internal and external validity

Award Number: R01DA065590
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/01/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2031

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Assessing whether use of fruit flavored ENDS relates to smoking reductions in people who smoke cigarettes: A data triangulation approach to maximize internal and external validity - SUMMARY ABSTRACT When considering restrictions on the sale of fruit-flavored ENDS, it is important to consider how such policies may impact people who smoke cigarettes and use ENDS to reduce harm from combustible cigarettes. If fruit flavors were found to have a beneficial effect on reducing harm from smoking combustible cigarettes, such effects should be considered in policies and regulations on flavored ENDS products in combination with evidence of their effect on nonsmoking youth and young adults. It is important to find out whether banning fruit flavors might reduce the chances that people who smoke combustible cigarettes will transition to ENDS use, or whether those who prefer fruit flavors would simply switch to tobacco-flavored ENDS and potentially reduce harm from smoking at the same rates. Currently, there is limited research with inconsistent findings on the role of fruit flavors in ENDS products in relation to smoking. The overall goal of this proposal is to assess how use of fruit flavored ENDS relates to reducing combustible cigarette use in people who smoke combustible cigarettes. First, we will study the potential effects of fruit flavor ENDS on the ‘full continuum’ of transitioning away from combustible cigarettes: Interest in using ENDS to reduce smoking → Initiation of ENDS use → Changes in smoking behavior → Long-term abstinence from smoking. Second, we will analyze whether there are significant differences in transitions from smoking to vaping and reducing exposure to tobacco smoke among individuals who smoke combustible cigarettes and who switch to ENDS with fruit vs. tobacco flavors. To maximize the scientific rigor of this project, we propose the strategic use of two complementary approaches to address our research question. We will use triangulation of an observational population-based study (Study 1 led by Dr Kasza) and a controlled randomized clinical trial (Study 2 led by Dr Goniewicz). Study 1 will include secondary data analyses of the US-nationally representative longitudinal PATH Study. Study 2 will be a naturalistic, randomized trial of fruit vs. tobacco flavored ENDS. Both studies will prospectively evaluate the role of fruit flavor in transitions away from cigarette smoking objectively verified by changes in biomarker levels. Because each proposed approach has its own unrelated assumptions, strengths, and weaknesses, results that agree across the two different methodologies will be less likely to be artefacts. Evidence from our naturalistic observational study (Study 1) will be triangulated with evidence from our experimental clinical trial (Study 2) to generate findings that are both robust and relevant for the protection of public health. This proposal addresses the High-Priority Research Topic Relevant to Behavior as defined in RFA-OD-25-001: The impact of ENDS (…) characteristics on tobacco product use behaviors (such as (…) switching and/or cessation-related behaviors) among (…) adults.


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 = $867,448 )
2026	2026	HEALTH RESEARCH, INC.	665 ELM ST	BUFFALO	NY	14203	ERIE	USA	Family Smoking Prevention and Tobacco Control Act Regulatory Research	000	1	8/3/2026	NEW	$867,448
														Subtotal = $867,448

Grand Total All Awards = $867,448

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Assessing whether use of fruit flavored ENDS relates to smoking reductions in people who smoke cigarettes: A data triangulation approach to maximize internal and external validity

Award Number: R01DA065590

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/01/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2031

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