A protocol for modifying progesterone to increase postpartum cigarette smoking abstinence and reduce secondhand smoke exposure in infants

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications Pub Date : 2024-11-06 DOI:10.1016/j.conctc.2024.101389

Nermine Abdelwahab , Alicia Allen , Katherine Harrison , Ashley Petersen , Sharon Allen

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引用次数: 0

Abstract

New interventions are necessary to increase postpartum abstinence from cigarette smoking. Sex hormones, specifically progesterone, have been found to be protective against drug-taking behaviors. Our pilot double-blind, randomized, controlled trial, although underpowered, suggested a trend toward a higher prevalence of smoking abstinence among postpartum participants receiving exogenous progesterone compared to those receiving placebo. This paper outlines the protocol used in our study to evaluate the efficacy of modifying progesterone to increase postpartum smoking abstinence and, subsequently, decrease secondhand smoke exposure in infants. In the intervention arm, participants will receive open-label exogenous oral progesterone (200 mg twice daily). Using a concurrent control group that does not receive progesterone treatment, we hypothesize that progesterone treatment will increase postpartum smoking abstinence as measured using a 7-day point prevalence at six months post-treatment allocation, as well as reduce smoking-related risk factors. Secondary objectives include examining the impact of this maternal smoking intervention on infant health. In addition to describing the protocol, we also discuss the protocol changes made due to the COVID-19 pandemic. Upon completion, this study will provide new information on how sex hormones may influence smoking cessation in postpartum populations, which can have broad public health implications.

Clinical trials registration #

NCT04783857.

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调整黄体酮以提高产后戒烟率并减少婴儿二手烟暴露的方案

有必要采取新的干预措施来提高产后戒烟率。研究发现，性激素（尤其是孕酮）对吸毒行为具有保护作用。我们的试验性双盲随机对照试验虽然研究力量不足，但结果表明，与服用安慰剂的参与者相比，服用外源性黄体酮的产后参与者的戒烟率呈上升趋势。本文概述了我们的研究方案，该方案旨在评估调整孕酮以提高产后戒烟率并进而减少婴儿二手烟暴露的疗效。在干预组中，参与者将接受开放标签的外源性口服黄体酮（200 毫克，每天两次）。我们假设黄体酮治疗将提高产后戒烟率（以治疗后 6 个月的 7 天点吸烟率来衡量），并减少与吸烟相关的风险因素。次要目标包括研究这种产妇吸烟干预对婴儿健康的影响。除了介绍方案外，我们还讨论了因 COVID-19 大流行而对方案做出的修改。这项研究完成后，将为性激素如何影响产后人群的戒烟提供新的信息，从而对公共卫生产生广泛的影响。临床试验注册 #NCT04783857。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Contemporary Clinical Trials Communications Pharmacology, Toxicology and Pharmaceutics-Pharmacology

CiteScore

2.70

自引率

6.70%

发文量

146

审稿时长

20 weeks

期刊介绍： Contemporary Clinical Trials Communications is an international peer reviewed open access journal that publishes articles pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from a wide range of disciplines including medicine, life science, pharmaceutical science, biostatistics, epidemiology, computer science, management science, behavioral science, and bioethics. Contemporary Clinical Trials Communications is unique in that it is outside the confines of disease specifications, and it strives to increase the transparency of medical research and reduce publication bias by publishing scientifically valid original research findings irrespective of their perceived importance, significance or impact. Both randomized and non-randomized trials are within the scope of the Journal. Some common topics include trial design rationale and methods, operational methodologies and challenges, and positive and negative trial results. In addition to original research, the Journal also welcomes other types of communications including, but are not limited to, methodology reviews, perspectives and discussions. Through timely dissemination of advances in clinical trials, the goal of Contemporary Clinical Trials Communications is to serve as a platform to enhance the communication and collaboration within the global clinical trials community that ultimately advances this field of research for the benefit of patients.