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R01DA054276

Project Grant

Overview

Grant Description
A Controlled Evaluation of Abstinence-Induced Withdrawal and Motivation to Vape/Smoke Among Daily ENDS Users vs. Cigarette Smokers - Project Summary/Abstract

Withdrawal is a key, multi-faceted component of tobacco/nicotine dependence. Because withdrawal symptoms are theorized to drive relapse, facets of withdrawal (e.g., craving, negative affect) are the targets of most current and emerging treatments.

Despite the central importance of withdrawal, and a voluminous literature on withdrawal from combustible cigarette smoking, we know little about withdrawal from electronic nicotine delivery systems (ENDS). To overcome critical barriers to progress in the field, we propose the first-ever prospective, controlled comparison of abstinence-induced withdrawal between ENDS vapers and cigarette smokers.

Participants will be 160 established daily vapers (including former smokers and dual users who smoke occasionally), 160 established daily smokers (including former vapers and dual users who vape occasionally), and (for exploratory comparisons) 50 established daily dual users, who smoke and vape daily. Participants will complete two 4-hour lab visits; the order of the ad lib use visit and the abstinent visit (which follows 24 hours of abstinence) will be randomized across participants.

To advance knowledge of ENDS withdrawal, we will employ state-of-the-science, multi-measure, multi-method assessments of key withdrawal facets: negative affect, craving, difficulty concentrating, restlessness, sleep, and appetite, as well as anhedonia/positive affect and somatic effects. We hypothesize that, for each facet, withdrawal magnitude will be lower among vapers compared to smokers.

To inform theory and intervention development, we will also evaluate the behavioral significance of ENDS withdrawal, testing the hypotheses that abstinence will increase the motivation to vape/smoke and this group difference will be accounted for (mediated) by vaper/smoker differences in one or more withdrawal facets.

Exploratory analyses will examine whether group differences in withdrawal are accounted for (mediated) by differential nicotine exposure, explore the role of individual differences (e.g., sex, rate of nicotine metabolism, expectancies), and examine differences among sub-groups of vapers.

The impact of this much-needed, detailed characterization of withdrawal from ENDS is enhanced by the inclusion of a comparator of great public health significance, cigarette smoking. In addition, by characterizing the specific withdrawal facets that drive motivation to vape/smoke, the proposed work will identify promising intervention targets for subsequent treatment development efforts.
Funding Goals
TO SUPPORT BASIC AND CLINICAL NEUROSCIENCE, BIOMEDICAL, BEHAVIORAL AND SOCIAL SCIENCE, EPIDEMIOLOGIC, HEALTH SERVICES AND HEALTH DISPARITY RESEARCH. TO DEVELOP NEW KNOWLEDGE AND APPROACHES RELATED TO THE PREVENTION, DIAGNOSIS, TREATMENT, ETIOLOGY, AND CONSEQUENCES OF DRUG ABUSE AND ADDICTION, INCLUDING HIV/AIDS. TO SUPPORT RESEARCH TRAINING AND RESEARCH SCIENTIST DEVELOPMENT. TO SUPPORT DISSEMINATION OF RESEARCH FINDINGS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) LEGISLATION IS INTENDED TO EXPAND AND IMPROVE THE SBIR PROGRAMS TO EMPHASIZE AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF TECHNOLOGY DEVELOPED THROUGH FEDERAL SBIR RESEARCH AND DEVELOPMENT, INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN THE SBIR PROGRAM. THE LEGISLATION INTENDS THAT THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION.
Place of Performance
Buffalo, New York 14214 United States
Geographic Scope
Single Zip Code
Analysis Notes
Amendment Since initial award the total obligations have increased 337% from $724,308 to $3,167,936.
The Research Foundation For The State University Of New York was awarded ENDS Withdrawal Comparison: Vapers vs. Smokers Project Grant R01DA054276 worth $3,167,936 from National Institute on Drug Abuse in June 2022 with work to be completed primarily in Buffalo New York United States. The grant has a duration of 4 years 10 months and was awarded through assistance program 93.279 Drug Abuse and Addiction Research Programs. The Project Grant was awarded through grant opportunity Electronic Nicotine Delivery Systems (ENDS): Population, Clinical and Applied Prevention Research (R01 - Clinical Trial Optional).

Status
(Ongoing)

Last Modified 4/25/25

Period of Performance
6/15/22
Start Date
4/30/27
End Date
65.0% Complete

Funding Split
$3.2M
Federal Obligation
$0.0
Non-Federal Obligation
$3.2M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01DA054276

Subgrant Awards

Disclosed subgrants for R01DA054276

Transaction History

Modifications to R01DA054276

Additional Detail

Award ID FAIN
R01DA054276
SAI Number
R01DA054276-3211501304
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Other
Awarding Office
75N600 NIH National Insitute on Drug Abuse
Funding Office
75N600 NIH National Insitute on Drug Abuse
Awardee UEI
LMCJKRFW5R81
Awardee CAGE
3GQT6
Performance District
NY-26
Senators
Kirsten Gillibrand
Charles Schumer

Budget Funding

Federal Account Budget Subfunction Object Class Total Percentage
National Institute on Drug Abuse, National Institutes of Health, Health and Human Services (075-0893) Health research and training Grants, subsidies, and contributions (41.0) $1,444,246 100%
Modified: 4/25/25