Using bupropion to help prevent smoking relapse after childbirth
Bupropion for the Prevention of Postpartum Smoking Relapse
PHASE4 · University of Minnesota · NCT04098874
This study tests if a medication called bupropion can help new moms who quit smoking stay smoke-free after giving birth.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT04098874 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of extended-release bupropion in preventing postpartum smoking relapse among pregnant women who have quit smoking. Participants will be randomly assigned to receive either bupropion or a placebo starting 4 to 10 days after delivery and continuing for 12 weeks. The study will involve regular data collection, including biological samples and validated questionnaires, to assess smoking behavior and hormonal changes. The aim is to determine if bupropion can help maintain abstinence from smoking during the postpartum period.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 to 45 who have quit smoking during pregnancy and are motivated to remain smoke-free after delivery.
Not a fit: Patients who currently use other forms of tobacco or nicotine, or those with certain psychiatric conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the rates of smoking relapse among new mothers, improving both maternal and infant health outcomes.
How similar studies have performed: Previous studies have shown promise in using bupropion for smoking cessation, suggesting potential success for this similar approach in postpartum women.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: Sharon Allen, MD — University of Minnesota
- Study coordinator: Katherine Harrison, MPH
- Email: harr0644@umn.edu
- Phone: 612-624-5377
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Postpartum Smoking Relapse