E-ASSIST

• Research type

  Research Study

• Full title

  E-cigarettes to Augment Stop Smoking In-person Support and Treatment with varenicline (E-ASSIST): a randomised controlled trial

• IRAS ID

  253312

• Contact name

  Lion Shahab

• Contact email

  lion.shahab@ucl.ac.uk

• Sponsor organisation

  University College London

• ISRCTN Number

  ISRCTN16931827

• Clinicaltrials.gov Identifier

  8323/003, UCL ethics ID; Z6364106/2018/05/79, UCL data protection reference number

• Duration of Study in the UK

  2 years, 1 months, 1 days

• Research summary

  Background and study aims:
  Self-reported use of e-cigarettes alongside varenicline in English stop smoking services (SSS) is associated with higher short-term abstinence rates than varenicline alone, so adding e-cigarettes to varenicline could improve quit success rates in clinical practice.

  This study aims to assess the benefit of offering an e-cigarette starter kit to adult smokers attempting to stop smoking with varenicline as determined by carbon monoxide (CO) verified abstinence from weeks 9-12 from the quit date.

  What does the study involve?:
  Participants will be randomised to either receive usual care plus an offer of a free third generation e-cigarette starter kit and advice on e-cigarette use (intervention group) or usual care alone (control group).
  After the pre-quit treatment episode, participants in both groups will receive the same treatment (Varenicline + behavioural support) as per standard stop smoking service practice and use of e-cigarettes will be recorded at subsequent visits until the final follow-up, twelve weeks after the target quit date.

  What are the possible benefits and risks?:
  There is no guarantee that taking part in the study will participants. However, it is possible that taking part in this study will improve participants’ chances of quitting smoking. Both the intervention and control condition involve usual care consisting of treatment with varenicline (currently the most effective pharmacotherapy) and behavioural support.

  If the study finds that adding e-cigarettes improve quit success rates in clinical practice then the treatment may be adopted by SSS and be recommended for smokers who are looking to quit smoking.

  There is little risk to taking part in this study. E-cigarettes, while not harmless, do not contain tobacco and therefore do not deliver the many harmful substances found in normal cigarettes. As a result they pose no increased risk compared to normal cigarettes. The most common side effects that people report experiencing when using e-cigarettes are mouth and throat irritation, nausea and sleep disturbance.

  The inclusion of e-cigarettes in this study is in line with current recommendations by Public Health England, the Royal College of Physicians and Cancer Research UK. The e-cigarettes provided are not currently licensed as a medicine, but they are regulated as a consumer product.

  Where is the study run?:
  Local authority stop smoking services in London and Cambridgeshire.

  When is the study starting and how long is it expected to run for?
  March 2019. The trial is expected to run for 18-24 months including participant recruitment, transfer of data and analysis and write up of the study outcomes.

  Who is funding the study?:
  Global Research Awards for Nicotine Dependence (GRAND, supported by Pfizer).
  Cancer Research UK

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  19/LO/0239

• Date of REC Opinion

  25 Feb 2019

• REC opinion

  Further Information Favourable Opinion