Preventing postpartum smoking relapse with hormone treatment

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

This study is testing if progesterone can help new and expecting moms who smoke stay smoke-free after giving birth.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 279 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: University of Minnesota (Academic / other)
• Locations: 1 site (Minneapolis, Minnesota)
• Trial ID: NCT04783857 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of progesterone in preventing postpartum smoking relapse among women who have recently given birth or are pregnant. The study will involve healthy pregnant women or postpartum women who have a history of smoking and are motivated to quit. Participants will receive a 12-week course of progesterone and will be monitored for six months through remote visits and self-administered surveys to assess their smoking behavior and hormone levels. The study also seeks to explore the impact of this intervention on infant health and examine differences in outcomes across racial and ethnic groups.

Who should consider this trial

Good fit: Ideal candidates are healthy pregnant women or postpartum women aged 18 to 45 with a recent history of smoking and a strong motivation to remain smoke-free.

Not a fit: Patients who are currently using nicotine replacement therapy or smoking cessation medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce smoking relapse rates in postpartum women, thereby improving health outcomes for both mothers and their infants.

How similar studies have performed: Previous studies have shown promise in using hormonal treatments for smoking cessation, but this specific approach is relatively novel.

Eligibility criteria

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.

Where this trial is running

Minneapolis, Minnesota

• University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Sharon Allen, MD, PhD — University of Minnesota
• Study coordinator: Katherine Harrison, MPH

Conditions Smoking; Smoking Cessation; Smoking Reduction