The Smoking Cessation in Pregnancy Incentives Trial (CPIT III)

• Research type

  Research Study

• Full title

  The Smoking Cessation in Pregnancy Incentives Trial (CPIT III): A multi-centre phase III Randomised Controlled Trial

• IRAS ID

  227489

• Contact name

  David M Tappin

• Contact email

  david.tappin@glasgow.ac.uk

• Sponsor organisation

  NHS Greater Glasgow & Clyde

• Duration of Study in the UK

  3 years, 2 months, 30 days

• Research summary

  Summary of Research
  BACKGROUND: Lifelong smokers lose 10 years of life. Smoking cessation by age 40 leads to a near normal lifespan. Eighty percent of women have a baby, most by age 40, making pregnancy an opportunity to help women quit before their health is irreversibly compromised. Few of the UK's current 130,000 pregnant smokers quit despite free counselling and Nicotine Replacement Therapy. Offering financial incentives for smoking cessation has worked in local single site trials including in Glasgow where the pilot study for this trial took place. NICE have asked for evidence from a multi-centre trial.

  AIMS: To conduct a pivotal phase III randomised controlled multi-centre trial to examine the effectiveness and cost effectiveness of offering financial incentives in the form of shopping vouchers to pregnant smokers to engage with smoking cessation services, quit smoking during pregnancy and stay quit after pregnancy.

  METHODS: This 39 month trial will recruit 940 smokers over 18-24 months in 2-4 UK centres and follow them until 6 months after birth. The extra cost and long-term benefits will be used to calculate the cost per Quality Adjusted Life Year gained. Pregnant smokers attending their first maternity booking appointment will be invited to participate. All participants will be offered usual smoking cessation services. In addition, the intervention group will be offered up to £400 of shopping vouchers, £50 if they attend counselling and set a quit date, £50 if proven quit 4-weeks later, £100 if quit after 12 weeks, and £200 if quit near the end of pregnancy. Self-report in late pregnancy and 6 months after birth will be verified by saliva cotinine, a nicotine metabolite.

  HOW RESULTS OF RESEARCH WILL BE USED: Trial results will provide sufficient evidence for NICE (PH26) Smoking: stopping in pregnancy and after childbirth – to decide if financial voucher incentives should be recommended or not.

  Summary of Results
  Offering financial incentives in the form of shopping vouchers of up to £400 on top of usual SSS support helped more than twice as many pregnant women who smoke to quit More women offered incentives took up the support offered by SSS compared with those not offered incentives Most women relapsed to smoking within six months of having their baby regardless of whether they were offered incentives or not Despite most women relapsing within six months, using financial incentives to help women to stop smoking would still be highly cost-effective over a lifetime and individuals would benefit through extra years of life (adjusted for quality of life) Usual care for pregnant women who smoke provided by maternity services and SSS varied considerably amongst study sites. Health professionals held a range of views on the acceptability of using financial incentives to help women to stop smoking and this had implications for their involvement with the study

• REC name

  West of Scotland REC 4

• REC reference

  17/WS/0173

• Date of REC Opinion

  16 Aug 2017

• REC opinion

  Favourable Opinion