[R01] Digital and Hormonal Biomarkers: Identifying Novel Targets for a Personalized Medicine Approach for Smoking Cessation in Women of Reproductive Age
Ente: National Institute on Drug Abuse
Scadenza: 2031-04-30
Importo max: 675.774 EUR
Paese: US
Descrizione
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.
Istituzione: ARKANSAS CHILDREN'S HOSPITAL RES INST
PI: Alicia M Allen
Progetto: 1R01DA063592-01A1
Settori: National Institute on Drug Abuse
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