drugset / Trial / NCT04098874
Bupropion for the Prevention of Postpartum Smoking Relapse
Phase 4
Recruiting
200 enrolled
University of Minnesota
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindPrevention
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.
Timeline
- Start
- 2020-01-01
- Primary completion
- 2026-07-31
- Completion
- 2026-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 300 mg | Oral |
Indications
No indication recorded.