NCT04098874

Bupropion for the Prevention of Postpartum Smoking Relapse

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: University of Minnesota · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Postpartum Smoking Relapse

Interventions

Type	Name	Description
DRUG	Bupropion Extended Release Oral Tablet	12 weeks postpartum of blinded study medication
DRUG	Placebo oral tablet	12 weeks postpartum of blinded placebo

Timeline

• Start date: 2020-01-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2019-09-23
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study