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- Published on: 5 July 2024
- Published on: 12 June 2024
- Published on: 5 July 2024SNAP2 trial is ethical
We share Polito’s concerns about harms from smoking in pregnancy; by finding effective ways to help pregnant women become smokefree, our work seeks to help eliminate these. We take our responsibilities to study participants very seriously. SNAP2 was approved by an independent research ethics committee which assessed all patient-facing materials, including the participant information sheet. After approval, any modifications to these documents require further approvals.
Giving nicotine to pregnant animals is widely accepted to be harmful for animal offspring.(1) It is logical to suspect similar effects in humans, and so, studies investigating nicotine use by pregnant women who do not smoke, would very likely be judged unethical. Consequently, the only robust information on how nicotine affects human pregnancies is from comparisons, within pregnant women who smoke, of those who do and do not use NRT (i.e. nicotine) for quitting. Systematic reviews of such studies indicate that NRT (nicotine) helps pregnant women stop smoking without having adverse effects on birth outcomes.(2, 3) Although there is currently insufficient research evidence to be completely sure, the most likely impact is that NRT (nicotine) used in pregnancy for quitting improves birth outcomes relative to continued smoking.(3) NRT has marketing autorisation for use in pregnancy in several European countries (e.g. in France, since 1997), many of which use sophisticated pharmacovigilance sy...
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None declared. - Published on: 12 June 2024SNAP2 “Baby, Me & NRT” Ignores Nicotine Risks
Clark and colleagues’ SNAP2 clinical trial is recruiting 1,320 pregnant UK smokers to the largest and possibly most aggressive pregnancy nicotine replacement therapy (NRT) cessation program to date. Noting accelerated nicotine metabolism during pregnancy, they contend that it’s “very likely that for NRT to work in pregnancy, higher nicotine doses and dosing consistency are needed than are currently used.” Recommending dual use of a nicotine patch plus either a nicotine inhaler, spray, or lozenges, they anticipate a 36-week pregnancy smoking cessation rate of 16% in the “Baby, Me & NRT” (BMN) intervention arm. As for safety, the authors state, “[W]e do not anticipate any harm being caused, and there is no adverse event monitoring.”[1]
Stated “Objective 1” of the “Baby, Me & NRT” behavioral program is to “strongly encourage high-dose, combination NRT use.” Objective 3 is to create the perception that NRT is “safe to use in pregnancy.”[2] Clark and colleagues SNAP2 Data Supplement 2 is a “Participant Information Sheet.” The sheet does not mention any known fetal nicotine risk. Instead, it states, “We do not foresee there being any risks from taking part in this study.” Data Supplement 3 is a “Consent Form.” The form does not mention any risk.[1]
Noting the gravity of potential smoking-induced fetal harms, Clark and colleagues assert that since 2000 “there has been expert consensus for using NRT to stop smoking in pregnancy.” But a simple “fetal + n...
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John R. Polito is the 1999 founder of WhyQuit, an abrupt nicotine
14 cessation website, and author of two cold turkey quitting books.