NCT04783857 Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
| NCT ID | NCT04783857 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Minnesota |
| Condition | Smoking |
| Study Type | INTERVENTIONAL |
| Enrollment | 171 participants |
| Start Date | 2022-04-14 |
| Primary Completion | 2027-06-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 171 participants in total. It began in 2022-04-14 with a primary completion date of 2027-06-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Sharon Allen, MD, PhD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT04783857 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Smoking. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04783857 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT04783857 currently recruiting?
Yes, NCT04783857 is actively recruiting participants. Contact the research team at harr0644@umn.edu for enrollment information.
Where is the NCT04783857 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT04783857 clinical trial?
NCT04783857 is sponsored by University of Minnesota. The principal investigator is Sharon Allen, MD, PhD at University of Minnesota. The trial plans to enroll 171 participants.