Journal Article

Smoking, nicotine and pregnancy 3 (SNAP3) trial: protocol for a randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction in pregnancy

Montgomery, Alan A, Holmes, Christopher M, Jiang, Yimin, Dickinson, Anne, Huang, Yue, Campbell, Katarzyna A, Bradshaw, Lucy, Jones, Matthew, Partlett, Christopher, Clark, Miranda M, Aveyard, Paul, Coleman, Tim

2025

Overview

IntroductionNicotine replacement therapy (NRT) helps pregnant women quit smoking. Usual National Health Service (NHS) cessation care in pregnancy starts only after women stop smoking and comprises behavioural support and NRT. NRT is stopped if women restart smoking. We hypothesised that NRT would have a bigger effect on cessation in pregnancy if used: (1) to reduce smoking before quitting (‘preloading’), (2) during brief smoking lapses after quitting and (3) to help those who cannot stop smoking, to reduce instead.Methods and analysisA two-arm parallel group, open-label, multicentre, assessor-blind randomised controlled trial. Participants are recruited at hospital antenatal clinics and other NHS settings throughout England and Wales or via social media advertising. Those enrolled are in antenatal care, <25 weeks’ gestation, smoke ≥5 daily cigarettes; accept referral for NHS stop smoking support and agree to set quit dates, try NRT and vape less than daily. Participants are randomised to: (1) usual care (UC) or (2) UC plus an intervention combining (1) NRT for preloading, (2) counselling to continue NRT during brief smoking lapses, and for those who cannot stop, (3) NRT to reduce smoking. The primary outcome is biochemically validated, smoking abstinence from 6 weeks after randomisation to 36 weeks gestation. Secondary outcomes include birth outcomes and cost per quality-adjusted life year. Questionnaires collect follow-up data augmented by medical record information. We anticipate quit rates of 10% and 15.9% in the control and intervention groups (OR=1.7). By recruiting 1430 participants, smoking, nicotine and pregnancy 3 should have 90% power (alpha=5%) to detect this effect. We will use the Economics of Smoking in Pregnancy model to estimate cost-effectiveness.Ethics and disseminationEthics approval was granted by the West Midlands—Coventry & Warwickshire Research Ethics Committee (REC reference: 21/WM/0172; Protocol number 21001; IRAS Project ID: 291236). Written informed consent will be obtained from all participants. Findings will be disseminated to the public, funders, relevant practice and policy representatives and other researchers.Trial registration numberISRCTN84798566.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Abstinence / Adult / Cigarettes / Consent / Cost analysis / Cost-Benefit Analysis / Counseling / England / Female / Humans / Multicenter Studies as Topic / Nicotine / Nicotine Replacement Therapy / Pregnancy / Pregnancy Complications - prevention & control / Pregnancy Complications - therapy / Prenatal care / Prenatal Care - methods / Protocol / Questionnaires / Randomized Controlled Trial / Randomized Controlled Trials as Topic / Smoking - therapy / Smoking and Tobacco / Smoking cessation / Smoking Cessation - methods / Smoking Reduction / Smoking Reduction - methods / Social networks / Tobacco smoke / Tobacco Use / Tobacco Use Cessation Devices / Transdermal medication / Wales / Womens health