drugset / Trial / NCT04098874

Bupropion for the Prevention of Postpartum Smoking Relapse

NCT04098874

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

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 300 mg Oral

Indications

No indication recorded.