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

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.

Trial registration: ClinicalTrials.gov NCT04098874.

Keywords: Bupropion; Postpartum relapse; Remote clinical trial; Smoking.

Figure 1.

Flow of study procedures for the original in-person and revised remote protocol