CompletedPhase 4

Bupropion for the Prevention of Postpartum Smoking Relapse

United States161 participantsStarted 2020-01-01

Plain-language summary

This two-arm, double-blind, placebo-controlled randomized clinical trial will enroll pregnant women who quit smoking after learning they were pregnant and are motivated to stay abstinent postpartum. Participants will be randomized to receive extended-release bupropion (active 300mg or placebo once daily beginning 4 to 10 days postpartum to 12 weeks post-randomization). All participants will complete the same data collection procedures (e.g., biological sample collection for hormone and cotinine analysis and completion of validated questionnaires) at baseline (gestational week 36), weekly from 4 to 10 days postpartum through 12 weeks post-randomization and at weeks 12, 24, 36 and 52 post-randomization.

Who can participate

Age range

18 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ability to provide informed consent * Age 18 to 45 years old * Stable health * 7-day point prevalence abstinence demonstrated at randomization * Lifetime history of at least 100 cigarettes smoked * Quit smoking during the current pregnancy * Self-report of intention to remain abstinent after delivery ≥ 7 on a 10 point Likert-type scale * Uncomplicated delivery * Denies plans to become pregnant again during the trial. * Full-term delivery ≥ 37 weeks gestation * Home within 10 days of delivery Exclusion Criteria: * Current use of other forms of tobacco or nicotine (e-cigs, chew, snuff, etc.) * Current use of cessation aids (e.g., varenicline, NRT) * Current use of illicit drugs or alcohol dependence * Current use of antidepressant medication * Bipolar disorder, eating disorder, or psychotic disorder based on the Structured Clinical Interview * Medications \& conditions that may increase the risk of taking bupropion (e.g., current or history of pulmonary embolus, stroke, heart disease, kidney disease, glaucoma, diabetes, seizure disorder, traumatic head injury, use of medications metabolized by CYP2D6) * Family history of seizures or seizure disorder * Maternal use of medications that lower seizure threshold * Newborn with an elevated risk of seizure

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Point prevalence smoking abstinence

Timeframe: 24 weeks post randomization

Trial details

NCT IDNCT04098874

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-31

View on ClinicalTrials.gov More Postpartum Smoking Relapse trials