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

Study Overview
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Brief Summary
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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.

Detailed Description
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This Good Clinical Practice aligned, double-blind, placebo-controlled, randomized clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators from two sites to enhance the diversity of the study sample and generalizability of results. The investigators will enroll healthy pregnant women (n=312) with a recent history of smoking and a desire to remain abstinent after childbirth. Using a randomized controlled trial design, participants will be randomized into one of two assignments: (1) Prog, (2) Placebo. Using procedures successfully implemented in our pilot study, participants will begin the 13-week study medication four days after childbirth. Participants will be followed for nine months with home/clinic visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

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

Conditions
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Smoking, Smoking Cessation, Smoking Reduction

Intervention / Treatment
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* Drug: Progesterone 200 MG Oral Capsule
* Other: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ability to provide informed consent, aged 18 to 40 years old (women who smoke are at increased risk for early menopause, 62 which may result in different hormonal patterns during the postpartum period; to avoid this confounder, women over 40 will be excluded), stable physical and mental health with either (a) a confirmed, uncomplicated pregnancy at gestational week 30or beyond, or (b) self-report the birth of a child within the past two years Pregnant individuals only: established prenatal care with written approval to participate fully in the study from their prenatal healthcare provider, history of ≥ 3 cigarettes a day during the six months prior to pregnancy self-report of motivation to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale, and willingness to use non-hormonal forms of contraceptives postpartum if sexually active during the 13-week study medication treatment period. Exclusion Criteria: current daily use of nicotine replacement therapy or smoking cessation medications, current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory, Postpartum individuals only: current use of exogenous hormones (including hormonal contraceptives), 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 use of illicit drugs or alcohol abuse, treatment for illicit drug use or alcohol use disorder within the last 3 months, and any condition that, in the opinion of the clinical team, precludes participation in the trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progesterone<br>Participants in this group will receive progesterone plus the placebo injection treatment | Drug: Progesterone 200 MG Oral Capsule<br>* Progesterone, 200mg, once daily, oral tablet/capsule<br>|
| Sham Comparator: Placebo<br>Participants in this group will receive the placebo oral pill and injection treatments | Other: Placebo Oral Tablet<br>* Placebo oral tablet, once per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the intervention smoking relapse postpartum | days to postpartum smoking relapse following randomization | 3 months post-randomization | 
| Efficacy of the intervention on smoking cessation postpartum | percentage of successful smoking cessation | 3months post-randomization | 
| Effects of maternal smoking intervention on infant health | The Infant State of Health Questionnaire (ISHQ) contains 28 items rated on a scale from 0 (not ill) to 4 (severely ill). Total scores range from 0 to 19 with higher scores indicating worse infant health. | 3 months post-randomization |