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Feasibility RCT of nicotine preloading for stopping smoking in pregnancy: a new approach to cessation

Project fact file

Professor Tim Coleman, Dr Sue Cooper and Professor Sarah Lewis
School / Division
Divisions of Primary Care; Epidemiology and Public Health
smoking Smoking in Pregnancy pregnancy nicotine replacement therapy
Fee band
Low-cost research
Date posted
July 2017

Project description


Smoking in pregnancy is the biggest avoidable cause of perinatal morbidity and mortality in the developed world.  Unfortunately, there aren’t many proven, effective interventions for helping pregnant smokers to stop. Nicotine replacement therapy (NRT) significantly improves cessation rates when used by non-pregnant smokers [1] but in pregnancy it has at best, borderline efficacy. [2] The standard method for using NRT is to set a quit date and on that day to start using NRT and to not smoke.  ‘Nicotine preloading’ is a new way of using NRT in which the smoker uses NRT when they are still smoking in the four weeks leading up to their quit date, then after the quit date they continue on NRT but cut out all cigarettes or smoked tobacco.  Although they aren’t specifically instructed to do so, when smokers use NRT as ‘preloading’ they smoke fewer cigarettes and exerience less cravings or urges to smoke and reduced craving is probably what makes preloading more effective than the usual way of using NRT. 

Two of this studentship’s supervisory team worked on the world’s largest trial of nicotine preloading, the Preloading Study; this NIHR HTA funded RCT enrolled 1786 participants and contributes substantially to what is known about preloading efficacy. [3]  An HTA monograph describing all trial findings will soon be published but we can reveal key details here.  The Preloading Study showed that preloading with NRT before a quit attempt in which NRT is used as a cessation treatment is more effective than standard use of NRT patches. Preloading used before quit attempts in which varenicine was used was less effecive; however, as varenicline isn’t licensed in pregnancy this has no bearing on the potential for using nicotine preloading in pregnancy. Additionally, as NRT is the mainstay of NHS treatment for smoking in pregnancy, preloading has the potential for enhancing both NRT efficacy and also the effectiveness of smoking cessation support delivered across the NHS. 

Pregnant women can be reluctant to use medication; previously we showed that even amongst pregnant smokers who use NRT, some women severely restrict how much NRT they use because they are concerned about potential harms to their babies.  [4] [5]  Hence, to persuade pregnant women to use NRT before they have stopped smoking will require prescriptions for NRT preloading to be accompanied by counselling which, as far as possible, address women’s concerns and reassures them that preloading is likely to be safer than smoking.

In this studentship a counselling and nicotine preloading intervention for pregnant smokers will be developed, refined and tested for feasibility and acceptability in a pilot RCT. The intervention’s  ultimate aim will be to increase pregnant smokers chances of  permanently stopping smoking.


  • To develop a counselling and nicotine preloading intervention for  pregnant smokers
  • To assess the acceptability of the developed counselling and nicotine preloading intervention as a cessation treatment for pregnant smokers
  • In a pilot RCT, to test the acceptabilityand feasibility of a counselling and nicotine preloading intervention for pregnant smokers 


Qualitative work will investigate pregnant smokers’ concerns about nicotine preloading.  Then, following a process that supervisors have previously used  [6], a prototype counselling and nicotine preloading  intervention will be developed and delivered to a cohort pregnant smokers.  Feedback will be obtained and the intervention will be refined and the process iteratively repeated with subsequent cohorts until the intervention is considered finalised.   The fully-refined intervention will then be delivered to pregnant smokers in a small RCT aimed at investigating the feasibility, safety and acceptability of this novel cessation approach.

Benefits and suitability as a PhD project

If successful, the student will successfully pilot a completely new theraputic intervention for smoking in pregnancy which, if effective , could easily be incorporated into the NHS. Hence, following a successful pilot trial, an ambitious student would be well placed to secure fellowship funding to further develop the evidence-base for this new treatment approach.  As reducing smoking in pregnancy is a priority internationally, any new intervention which can help achieve this will be of intense, global interest. 

The successful student would be well supported by our wider research group. We are world leaders in the conduct of trials for smoking cessation interventions in pregnancy. We are also about to conclude a project which aims to improve the quality of counselling used in smoking cessation support for pregnant smokers across the NHS and have recently started an NIHR programme in which a different intervention for cessation in pregnancy is being developed and tested using similar methods to those described above. The student will be encouraged to develop additional hypotheses of interest and make a unique academic contribution. 

Key references 

  1. Stead, L.F., et al., Nicotine replacement therapy for smoking cessation. Cochrane Database Syst Rev, 2012. 11: p. CD000146.
  2. Coleman, T., et al., Pharmacological interventions for promoting smoking cessation during pregnancy. Cochrane Database of Systematic Reviews, 2015(12): p. CD010078.
  3. Lindson-Hawley, N., et al., Nicotine patch preloading for smoking cessation (the preloading trial): study protocol for a randomized controlled trial. Trials, 2014. 15: p. 296.
  4. Bowker, K., et al., Understanding pregnant smokers’ adherence to nicotine replacement therapy during a quit attempt: a qualitative study. Nicotine & Tobacco Research, 2015.
  5. Dhalwani, N.N., et al., Prescribing of nicotine replacement therapy in and around pregnancy: a population-based study using primary care data. Br J Gen Pract, 2014. 64(626): p. e554-60.
  6. Marsh, J., et al., Protecting children from secondhand smoke: a mixed-methods feasibility study of a novel smoke-free home intervention. Pilot and Feasibility Studies, 2016. 2(1): p. 53.




School of Medicine

University of Nottingham
Medical School
Nottingham, NG7 2UH

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