About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Progesterone 200 MG Oral Capsule
DrugProgesterone, 200mg, once daily, oral tablet/capsule
Treatment groups
Trial outcomes
Primary outcomes
Smoking abstinence at Month 6
Child health assessed as smoke exposure and acute infant health.
Sponsors and contacts
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University of Minnesota
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator