Modifying Progesterone and Estradiol Levels to Prevent Postpartum Cigarette Smoking Relapse and Reduce Secondhand Smoke Exposure in Infants and Children

NCT04783857 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: FMCH-2021-29672R01HD100418
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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 effects of this maternal smoking intervention on infant health.
• Examine racial and ethnic differences in intervention outcomes.

Conditions

Smoking; Smoking Cessation; Smoking Reduction

Outcome Measures

Primary Outcomes (2)

• Smoking abstinence at Month 6

  6 months

• Child health assessed as smoke exposure and acute infant health.

  6 months

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Participants in this group will receive progesterone

Drug: Progesterone 200 MG Oral Capsule

Group 2

NO INTERVENTION

Participants in this group will not receive progesterone

Interventions

Progesterone 200 MG Oral Capsule DRUG

Progesterone, 200mg, once daily, oral tablet/capsule

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify 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
• 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

You may not qualify 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 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.

Sponsors & Collaborators

• University of Minnesota: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 39618477 DERIVED

MeSH Terms

Conditions

Smoking; Smoking Cessation; Smoking Reduction

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Officials

• Sharon Allen, MD, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Harrison, MPH

CONTACT

612-624-5377; harr0644@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: April 14, 2022
• Primary Completion (Estimated): June 2, 2026
• Study Completion (Estimated): June 2, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Locations

US (1)