RECRUITING

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

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Conditions

SmokingSmoking CessationSmoking Reduction

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-04-14
Study Completion:2025-06-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04783857

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.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Ability to provide informed consent,
  2. * Aged 18 to 45 years old
  3. * Self-reported stable physical and mental health
  4. 1. self-report uncomplicated pregnancy at gestational week 30 or beyond, or
  5. 2. self-report the birth of a child within the past 6 months
  6. * History of ≥ 4 cigarettes per month during the six months prior to pregnancy
  7. * At enrollment, self-report of motivation to become and/or remain abstinent after delivery ≥ 6 on a 10 point Likert-type scale
  8. * Willingness to protect against pregnancy following day 0 to week 12 of the study
  9. * Participants must live in the continental US and have a device to fully participate in the protocol
  1. * Current daily use of nicotine replacement therapy or smoking cessation medications, with the exception of e-cigarettes
  2. * Current major depressive disorder based on the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory
  3. * 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),
  4. * Current or within the past 3 months treatment for illicit drug use or alcohol use
  5. * Any condition or issue that, in the opinion of the clinical team, precludes participation in the trial.

Contacts and Locations

Study Contact

Katherine Harrison, MPH
CONTACT
612-624-5377
harr0644@umn.edu

Principal Investigator

Sharon Allen, MD, PhD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

University of Minnesota
Minneapolis, Minnesota, 55455
United States

Collaborators and Investigators

Sponsor: University of Minnesota

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-14
Study Completion Date2025-06-02

Study Record Updates

Study Start Date2022-04-14
Study Completion Date2025-06-02

Terms related to this study

Additional Relevant MeSH Terms

  • Smoking
  • Smoking Cessation
  • Smoking Reduction