← Back to all trials
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.
Source: ClinicalTrials.gov (NCT04783857). StuddyBuddy aggregates publicly available trial information.