Bupropion for the Prevention of Postpartum Smoking Relapse
University of Minnesota
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.
Eligibility
- Age range
- 18–45 years
- Sex
- Female
- Healthy volunteers
- Yes
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-cig…
Interventions
- DrugBupropion Extended Release Oral Tablet
12 weeks postpartum of blinded study medication
- DrugPlacebo oral tablet
12 weeks postpartum of blinded placebo
Location
- University of MinnesotaMinneapolis, Minnesota