This phase IV trial studies how well bupropion works in helping women who quit smoking during pregnancy to continue not smoking after they give birth. Bupropion is an approved drug for the treatment of depression and to help people quit smoking. Giving bupropion may help women remain smoke-free after delivery.
Additional locations may be listed on ClinicalTrials.gov for NCT04098874.
Locations matching your search criteria
United States
Minnesota
Minneapolis
University of Minnesota/Masonic Cancer CenterStatus: Active
Contact: Sharon Allen
Phone: 612-624-2446
PRIMARY OBJECTIVES:
I. Determine the impact of bupropion hydrochloride controlled-release (bupropion) compared to placebo on postpartum smoking relapse among women who quit smoking during pregnancy.
II. Examine the impact of bupropion compared to placebo on modifiable risk factors for postpartum smoking relapse (e.g., stress, fatigue, weight concerns, depression and cigarette cravings).
EXPLORATORY OBJECTIVE:
I. Examine the impact of mediators and moderators on the intervention to provide a greater understanding of how targeting postpartum smoking relapse with bupropion may influence behavioral change.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive bupropion orally (PO) once daily (QD) for 12 weeks in the absence of unacceptable toxicity.
ARM II: Patients receive a placebo PO QD for 12 weeks.
After randomization, patients are followed up at 12, 24, 36, and 52 weeks.
Lead OrganizationUniversity of Minnesota/Masonic Cancer Center
Principal InvestigatorSharon Allen
