Status:
RECRUITING
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Smoking
Smoking Cessation
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
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 effect...
Detailed 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 generalizabil...
Eligibility Criteria
Inclusion
- Ability to provide informed consent,
- Aged 18 to 45 years old
- Self-reported stable physical and mental health
- self-report uncomplicated pregnancy at gestational week 30 or beyond, or
- 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
- 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.
Key Trial Info
Start Date :
April 14 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 2 2026
Estimated Enrollment :
279 Patients enrolled
Trial Details
Trial ID
NCT04783857
Start Date
April 14 2022
End Date
June 2 2026
Last Update
July 8 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455