Smoking, Nicotine and Pregnancy 3 (SNAP 3) Trial
Research type
Research Study
Full title
Open-label randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction: impact on smoking in pregnancy
IRAS ID
291236
Contact name
Tim Coleman
Contact email
Sponsor organisation
Univeristy of Nottingham
ISRCTN Number
ISRCTN84798566
Duration of Study in the UK
3 years, 2 months, 26 days
Research summary
Nicotine replacement therapy (NRT) provides nicotine without toxins contained in cigarette smoke; when used with specialist support, it helps pregnant women stop smoking. The NRT instruction booklet includes use for preloading, reduction and lapse recovery; studies suggest that allowing to smoke and use NRT together helps with stopping. Currently, NHS stop smoking support advises pregnant women not to smoke when using NRT. This study will test whether relaxing this message could help pregnant women to quit and improve babies’ health.
The aim of this study is to test support for the following 3 uses of NRT:
• Preloading - using nicotine patches for a short time when still smoking but preparing to stop.
• NRT in ‘slip ups’ (smoking occasional cigarettes) – advice to keep on with NRT during short ‘slip ups’; this may help them stop smoking for good.
• For women who cannot quit, using NRT to smoke less – this could also help them stop smoking; if not, breathing in less harmful cigarette smoke should make babies healthier.
We will recruit 1430 pregnant women (≤25 weeks pregnant) who smoke, from antenatal hospital, community settings and via social media. Participants will be randomly assigned into two groups. One group will receive usual NHS stop smoking support (counseling and NRT). The second, will also receive support with preloading NRT patches for up to 4 weeks before they try to quit and using NRT during ‘slip-ups’. Women who cannot stop after 6 weeks will receive support and an offer of NRT to help them smoke less.
We will collect saliva and breath samples before/during the study to measure nicotine and CO levels respectively. We will ask women about their smoking 6 weeks into the study and when they are 36 weeks pregnant. We will collect data on birth outcomes. Data will be compared between two groups.REC name
West Midlands - Coventry & Warwickshire Research Ethics Committee
REC reference
21/WM/0172
Date of REC Opinion
3 Aug 2021
REC opinion
Favourable Opinion