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

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04783857
• Other study ID #: FMCH-2021-29672
• Secondary ID: R01HD100418
• Status: Recruiting
• Phase: Phase 4
• Start date: April 14, 2022
• Est. completion date: June 2, 2025

Study information

• Verified date: February 2024
• Source: University of Minnesota
• Contact: Katherine Harrison, MPH
• Phone: 612-624-5377
• Email: harr0644[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This Good Clinical Practice clinical trial will be implemented by an experienced, transdisciplinary, and productive team of investigators to enhance the diversity of the study sample and generalizability of results. We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US) and will participant in an observational arm of the study. Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. All participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 279
• Est. completion date: June 2, 2025
• Est. primary completion date: June 2, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Recurrence
• Smoking
• Smoking Cessation
• Smoking Reduction

Intervention

Drug:
• Progesterone 200 MG Oral Capsule
Progesterone, 200mg, once daily, oral tablet/capsule

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence at Month 6		6 months
Primary	Child health assessed as smoke exposure and acute infant health.		6 months