Recruiting

Prog

Sponsor:

University of Minnesota

Code:

NCT04783857

Conditions

Smoking

Smoking Cessation

Smoking Reduction

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Progesterone 200 MG Oral Capsule

Study Details

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

Study ID

NCT04783857

Start date

Apr 14, 2022

Status verified date

Jul, 2026

Completion date

Jun 2, 2027

Anticipated

Primary completion date

Jun 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

171 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Group 1

Participants in this group will receive progesterone

no intervention: Group 2

Participants in this group will not receive progesterone

Interventions

Progesterone 200 MG Oral Capsule

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

Primary outcome measure

  • Smoking abstinence at Month 6 [ Time Frame: 6 months ]
  • Child health assessed as smoke exposure and acute infant health. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Katherine Harrison, MPH

612-624-5377harr0644@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

More Information

Sponsor

University of Minnesota

Last update posted

Jul 13, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-07-13.