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Recruiting NCT04783857

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

Conditions: Smoking, Smoking Cessation, Smoking Reduction

Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 171
Sponsor: University of Minnesota

Location: University of Minnesota Minneapolis Minnesota

Summary

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.

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04783857). StuddyBuddy aggregates publicly available trial information.