Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

Summary

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Description

This Good Clinical Practice aligned, double-blind, placebo-controlled, randomized clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators from two sites to enhance the diversity of the study sample and generalizability of results. The investigato...

This Good Clinical Practice aligned, double-blind, placebo-controlled, randomized clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators from two sites to enhance the diversity of the study sample and generalizability of results. The investigators will enroll healthy pregnant women (n=312) with a recent history of smoking and a desire to remain abstinent after childbirth. Using a 2×2 factorial design, participants will be randomized into one of four assignments: (1) Prog+DMPA, (2) Prog+placebo, (3) placebo+DMPA, and (4) placebo+placebo. Using procedures successfully implemented in our pilot study, participants will begin the 13-week study medication four days after childbirth. Participants will be followed for nine months with home/clinic visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

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