Digital and Hormonal Biomarkers: Identifying Novel Targets for a Personalized Medicine Approach for Smoking Cessation in Women of Reproductive Age - Project Summary/Abstract Evidenced-based cigarette smoking cessation interventions are less efficacious in women as compared to men. Women are also more vulnerable to smoking-related morbidity and mortality compared to men. The role of ovarian hormones (e.g., progesterone, estradiol) in cigarette smoking in women of reproductive age remains unknown, despite ample compelling evidence from preclinical literature. Utilizing today’s technology, we can gain a better understanding how ovarian hormonal fluctuations contribute to smoking behavior, as well as how they can be used to create effective smoking cessation interventions. Specifically, three major outstanding limitations exist in the clinical literature on ovarian hormones and smoking cessation that need to be addressed to improve generalizability (i.e., inclusion of women who are using hormonal contraceptives and/or have irregular menstrual cycles), increase scientific rigor (i.e., expansion to measurement of other hormones; e.g., ethinyl estradiol), and expand scientific knowledge. Beyond these limitations, an additional gap includes a lack of research on the identification of digital biomarkers that are known to vary with hormonal fluctuation (e.g., increase in body temperature during ovulation). Overall, these existing limitations and gaps in knowledge severely limit the opportunities to apply hormonal and/or digital biomarkers to personalized medicine approaches in smoking cessation for women of reproductive age. The overall goal of his national fully-remote natural-experiment study is to identify hormonal and/or digital biomarkers that are predictive of smoking cessation outcomes in a diverse sample of biological females utilizing innovative methodology. Participants will complete four types of data collection: (a) measurement ovarian hormone measurement via urine dip stick testing (e.g., progesterone) and dried blood spot testing (e.g., ethinyl estradiol), (b) monitoring of physiological changes (e.g. distal body temperature) via sensor measurement, (c) self-administered validated surveys, and (d) measurement of expired carbon monoxide. Our primary outcome will be cigarette smoking cessation, with secondary outcomes including level of use (e.g., cigarettes/day), motives for use (e.g., craving), and smoking cessation intervention engagement (e.g., completion of coaching sessions). Upon completion of this project, regardless of outcome, the data collected here will advance the knowledge on how female physiology influences smoking. Further, the identification of novel hormonal and/or digital biomarkers will inform the development of personalized medicine approaches for smoking cessation tailored to the needs of women of reproductive age in direct response to NOT-OD-24-079.
