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

Launched by UNIVERSITY OF MINNESOTA · Mar 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how adjusting levels of hormones, specifically progesterone and estradiol, can help new mothers avoid going back to smoking after they give birth. The researchers want to see if this approach can not only reduce the chances of mothers relapsing into smoking, but also improve the health of their infants and understand if different racial and ethnic groups respond differently to this treatment.

To take part in this study, you need to be a woman aged 18 to 45 who is either in the later stages of pregnancy (at least 30 weeks) or has given birth in the last six months. You should also have a history of smoking at least four cigarettes a month before becoming pregnant and be motivated to stay smoke-free after delivery. Participants will need to be willing to avoid getting pregnant during the study and have access to a device to participate. If you meet these criteria and are interested, this study could help you and your baby by finding new ways to prevent smoking relapse and reduce secondhand smoke exposure.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Ability to provide informed consent,
• • Aged 18 to 45 years old
• • Self-reported stable physical and mental health
• • 1. self-report uncomplicated pregnancy at gestational week 30 or beyond, or
• • 2. self-report the birth of a child within the past 6 months
• • History of ≥ 4 cigarettes per month during the six months prior to pregnancy
• • At enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale
• • Willingness to protect against pregnancy following day 0 to week 12 of the study
• • Participants must live in the continental US and have a device to fully participate in the protocol
• Exclusion Criteria:
• • Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
• • Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory
• • Contraindication to progesterone treatment (e.g., current use of drugs that may inhibit CYP3A4; current or history of deep vein thrombosis, pulmonary embolus, clotting or bleeding disorder, hypertension, stroke, heart disease, or liver dysfunction or disease; or peanut allergy),
• • Current or within the past 3 months treatment for illicit drug use or alcohol use
• • Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.