This phase IV trial evaluates whether modifying hormones (progesterone) levels improves quitting smoking (cessation) and prevents a return to smoking (relapse) in women after pregnancy (postpartum). Pregnancy provides a strong motivation for many women to quit or want to quit cigarette smoking for their health and the health of their families. However, up to 90% of women who are able to quit smoking during pregnancy relapse within 12 months of delivery. In addition to the health consequences for new mothers, cigarette smoke exposure has health consequences for children, including increased risk of developing health and behavioral problems. Unfortunately, effective postpartum relapse interventions are lacking. Progesterone is a naturally occurring hormone that increases during pregnancy, and then drops after childbirth. Higher levels of progesterone seem to help some women quit smoking and stay quit. Increasing progesterone levels with supplementation may help pregnant women quit smoking and remain smoke-free after delivery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04783857.
Locations matching your search criteria
United States
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer CenterStatus: Active
Contact: Sharon Allen
Phone: 612-624-2446
PRIMARY OBJECTIVES:
I. Determine the efficacy of therapeutic progesterone (progesterone) in preventing postpartum smoking relapse and reducing smoking relapse risk factors.
II. Examine the effects of this maternal smoking intervention on infant health.
EXPLORATORY OBJECTIVE:
I. Examine racial and ethnic differences in intervention outcomes.
OUTLINE: Participants in Minnesota are assigned to Arm I and participants outside of Minnesota are assigned to Arm II.
ARM I: Participants receive progesterone orally (PO) twice daily (BID) for 12 weeks in the absence of unacceptable toxicity. Participants also receive smoking cessation or relapse prevention counseling and undergo collection of dried blood spot samples throughout the trial.
ARM II: Participants do not receive progesterone. Participants receive smoking cessation or relapse prevention counseling and undergo collection of dried blood spot samples throughout the trial.
After completion of study intervention, participants are followed up at month 6.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorSharon Allen
