RECRUITING

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

Description

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.

Study Overview

Study Details

Study overview

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.

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

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

Condition
Smoking
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55455

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Sharon Allen, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2025-06-02