Smoking study: Progesterone
Official title Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
ClinicalTrials.gov ID: NCT04783857
What this study is testing
What is Progesterone 200 MG Oral Capsule?
This is an investigational oral capsule being studied to help prevent smoking relapse after childbirth. is designed to provide a steady level of the hormone progesterone in the body.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study checks if a hormone treatment helps prevent smoking relapse after birth. It also looks at how this affects infant health and if results differ by race or ethnicity.
- Who it's for
- New mothers who smoke or have recently quit smoking.
- What's involved
- Participants will receive a hormone treatment and take part in a program to help them stay smoke-free. The study will monitor their smoking habits and their babies' health.
- Time commitment
- The source text does not specify the duration or number of visits.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only
You may be able to join if
- 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
You likely can't join if
- 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 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.
See the full eligibility criteria
- 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
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Minneapolis, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Minneapolis, Minnesota, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.