R01MD018123

4th Generation E-Cigarettes in African American Smokers: Reducing Harm and Quitting Combustible Cigarettes in Dual Users - Project Summary

E-cigarettes (EC) have proven to be an effective harm reduction strategy for adult combustible cigarette smokers who exclusively switch to EC. However, African Americans (AA) have been slower to adopt EC and are underrepresented in EC research, resulting in a lack of knowledge about EC as a harm reduction strategy for a group that experiences the highest risk of tobacco-related morbidity and mortality.

There is limited information available about 4th generation nicotine salt-based pod systems (NSPS), which are the leading class of EC. NSPS EC contains high nicotine concentrations with rapid nicotine delivery, making exclusive switching easier. Our pilot data provide strong preliminary evidence of EC as a harm reduction strategy for AA smokers, but there is an urgent need for a fully powered trial with longer follow-up.

Furthermore, to enhance EC as a harm reduction strategy, interventions are needed to support exclusive switching in dual cigarette-EC users who initially fail to quit. Currently, no such interventions exist. A recent open-label study found that varenicline (VAR) helped dual users eliminate cigarette use, but this strategy has not been tested in a randomized controlled trial. Failing to intervene with dual users is a missed opportunity among a group that comprises the largest proportion of EC users (> 50%) and is already motivated to reduce harm from smoking.

The objectives of this application are to:

1) Compare short- and long-term harm reduction and abuse liability potential (i.e., withdrawal, craving, dependence) of a NSPS EC in AA exclusive EC, dual cigarette-EC, and exclusive cigarette users.
2) Characterize factors that predict who switches fully, partially, or not at all.
3) Examine if harm reduction can be further enhanced by treating dual users with VAR to eliminate cigarette smoking.

These objectives will be accomplished by conducting a 6-week open-label trial of a NSPS EC and counseling to facilitate a complete switch to EC in AA cigarette smokers (N=500) who are not interested in quitting all nicotine products but are interested in switching to EC. We will enhance harm reduction potential and capitalize on a missed opportunity by offering dual users additional support to make a complete switch. At six weeks, those who are dual users (N= ~221) will receive an additional 12 weeks of the NSPS EC, ongoing counseling to make a complete switch, and be randomized to receive 12 weeks of VAR or placebo (PBO) to support quitting combustible cigarettes. Follow-up will continue for one year, providing the first evidence on the long-term harm reduction potential of NSPS EC.

The current study is the first to examine the short- and long-term harm reduction potential of NSPS EC in a priority population and the first to examine pharmacological support for dual cigarette-EC users in making a complete switch to EC. The findings have the potential to support EC as a harm reduction strategy among a disparate group that arguably stands to benefit from it the most. Additionally, this research will contribute to the overall goal of reducing tobacco-related morbidity and mortality and narrow the health disparity gap for AA smokers.

University Of Kansas Medical Center Research Institute

NOT APPLICABLE

93.307 - Minority Health and Health Disparities Research

National Institute for Minority Health and Health Disparities (NIMHD) [HHS - NIH]

Kansas City, Kansas 66160 United States

Single Zip Code

Electronic Nicotine Delivery Systems (ENDS): Population, Clinical and Applied Prevention Research (R01 - Clinical Trial Optional) (PAR-18-847)

Amendment Since initial award the total obligations have increased 391% from $642,875 to $3,153,334.