SmokingPhase 4NCT04783857
Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children
A Phase 4 study testing Progesterone 200 MG Oral Capsule in people with Smoking and Smoking Cessation, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Smoking, Smoking Cessation, Smoking Reduction
- What is being tested?
- Progesterone 200 MG Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 2 Jun 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Katherine Harrison, MPH
About this study
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.
Read the 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 generalizability of results. We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US) and will participant in an observational arm of the study. Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. All participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.
- Conditions
- Smoking, Smoking Cessation, Smoking Reduction
- Being tested
- Progesterone 200 MG Oral Capsule
- Medical subject headings
- Smoking, Smoking Cessation, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progesterone 200 MG Oral CapsuleDrug
Progesterone, 200mg, once daily, oral tablet/capsule
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Participants in this group will receive progesterone Receives: Drug: Progesterone 200 MG Oral Capsule |
| Group 2 | No intervention | Participants in this group will not receive progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking abstinence at Month 6
Measured: 6 months
Child health assessed as smoke exposure and acute infant health.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start14 Apr 2022
- Primary completion2 Jun 2027 (estimated)
- Study completion2 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Sharon Allen, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04783857
- Sponsor's protocol ID
- FMCH-2021-29672
- Other IDs
- R01HD100418
- Status last verified
- Jul 2026
- First submitted
- 2 Mar 2021
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Abdelwahab N, Allen A, Harrison K, Petersen A, Allen S. A protocol for modifying progesterone to increase postpartum cigarette smoking abstinence and reduce secondhand smoke exposure in infants. Contemp Clin Trials Commun. 2024 Nov 6;42:101389. doi: 10.1016/j.conctc.2024.101389. eCollection 2024 Dec.
PubMed 39618477
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- FMCH-2021-29672
- Conditions
- Smoking, Smoking Cessation, Smoking Reduction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 171 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 2 Jun 2027 (estimated)
- Study completion
- 2 Jun 2027 (estimated)
- First posted
- 5 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 generalizability of results. We will enroll healthy pregnant women (following enrollment, all subsequent study procedures will be completed postpartum) or postpartum women on hormonal birth control or no hormonal birth control with either a recent history of smoking and a desire to remain abstinent after childbirth, or who are currently smoking and motivated to quit smoking. Participants will be recruited throughout the continental United States (US) and will participant in an observational arm of the study. Participants living in Minnesota (our clinical site) will receive a 12-week course of exogenous progesterone. All participants will be followed for six months with remote visits, self-administered surveys, and self-collection of dried blood spots to measure hormones and smoking-related biomarkers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Progesterone 200 MG Oral CapsuleParticipants in this group will receive progesterone |
| Group 2 | No intervention | –Participants in this group will not receive progesterone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Ability to provide informed consent,
- Aged 18 to 45 years old
- Self-reported stable physical and mental health
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progesterone 200 MG Oral CapsuleProgesterone, 200mg, once daily, oral tablet/capsule | Drug | Group 1 |
Primary outcome
Smoking abstinence at Month 6
Time frame: 6 months
Child health assessed as smoke exposure and acute infant health.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Derived from this study: PubMed 39618477Abdelwahab N, Allen A, Harrison K, Petersen A, Allen S. A protocol for modifying progesterone to increase postpartum cigarette smoking abstinence and reduce secondhand smoke exposure in infants. Contemp Clin Trials Commun. 2024 Nov 6;42:101389. doi: 10.1016/j.conctc.2024.101389. eCollection 2024 Dec.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sharon Allen, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Progesterone 200 MG Oral Capsule in people with Smoking and Smoking Cessation, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Harrison, MPH (612-624-5377, harr0644@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking abstinence at Month 6 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04783857, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.