Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT04783857
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.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT04783857
Study Brief:
Protocol Section:
NCT04783857