Bupropion for postpartum smoking relapse: A remote protocol for a two-arm, double-blind, placebo-controlled randomized clinical trial

Sharon Allen, Janet Thomas, Katherine Harrison, Rebecca L. Emery, Ashley Petersen, Jonathan P. Winickoff, Sandra Japuntich

Research output: Contribution to journalArticlepeer-review

Abstract

Cigarette smoking among postpartum women remains a significant public health problem despite known health risks to women and their newborns. It is estimated that over 50% of women quit smoking during pregnancy but 90% relapse by one year. Safe and effective postpartum relapse prevention strategies are urgently needed. In an attempt to address this deficit, we will investigate the efficacy of bupropion vs. placebo as a smoking relapse prevention aid in postpartum women. The objective of this paper is to detail an approach to investigate bupropion's efficacy for preventing postpartum smoking relapse among women who quit smoking during pregnancy. Specifically, we designed a two-arm, double-blind, placebo-controlled randomized trial testing the efficacy of bupropion vs. placebo as a relapse prevention tool. Mothers of healthy infants who quit smoking while pregnant will be stratified based on current or past history of major depressive disorder or persistent depressive disorder and randomized to receive either active (bupropion XL 300 mg/day) or placebo medication for 12 weeks. To respond to safety concerns associated with participant and staff exposure to COVID-19, we revised our original protocol and present procedures which allow our trial to be conducted entirely remotely. Primary and secondary outcomes will be assessed at weeks 12, 24, 36 and 52 post-randomization. The primary outcome is 7-day point prevalence abstinence at 24 weeks. Results of this work have the potential to positively impact women and their children by promoting lifelong cessation, eliminating secondhand smoke exposure, and modelling of abstinence to children.

Original languageEnglish (US)
Article number106352
JournalContemporary Clinical Trials
Volume105
Early online dateMar 9 2021
DOIs
StatePublished - Jun 2021

Bibliographical note

Funding Information:
This work was supported by NIH / NIDA R01DA047287.

Funding Information:
Rebecca Emery's time was supported by the National Center for Advancing Translational Science (grant numbers TL1 R002493 , PI: Fulkerson and UL1 TR002494 , PI: Blazar).

Publisher Copyright:
© 2021 Elsevier Inc.

Keywords

  • Bupropion
  • Postpartum relapse
  • Remote clinical trial
  • Smoking

PubMed: MeSH publication types

  • Clinical Trial Protocol
  • Journal Article
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

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