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

Recruiting now · Phase 4

Conditions studied: Smoking, Smoking Cessation, Smoking Reduction

In brief

The investigators aim to address the following specific aims: * Determine the efficacy of Prog in preventing postpartum smoking relapse and reducing smoking relapse risk factors. * Examine the effects of this maternal smoking intervention on infant health. * Examine racial and ethnic differences in intervention outcomes.

Key facts

Study ID

NCT04783857

Run by

University of Minnesota

People needed

171

Starts

2022-04-14

Expected to finish

2027-06-02

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Ability to provide informed consent,
• Aged 18 to 45 years old
• Self-reported stable physical and mental health
• self-report uncomplicated pregnancy at gestational week 30 or beyond, or
• 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

You may not qualify if…

• 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.

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States (enrolling)

Full record on ClinicalTrials.gov

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