Home › Smoking and Youth › NCT04783857
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
RecruitingPhase 4
Who can join
Ages 18 to 45 · Women
Full 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.
About the study
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.
What is being tested
- Progesterone 200 MG Oral Capsule (drug)
Sponsor: University of Minnesota · Participants: 171 · Started: Apr 14, 2022
Contact the study team
- Katherine Harrison, MPH · Phone: 612-624-5377
Official record on ClinicalTrials.gov — NCT04783857
Locations in the U.S.
| Minnesota | University of Minnesota, Minneapolis |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.