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New treatment option for Smoking
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?
Progesterone 200 MG Oral Capsule is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for smoking.
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
- 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.
- 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 history of deep vein thrombosis, pulmonary...
- 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's taking place
- 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 - 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?
Study sites include Minneapolis, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.