The STATUS trial (STudy of Adaptive Treatment in AOD and MH services Users who Smoke) aims to find out if using Champix plus other medicines used for smoking cessation – in this case nicotine replacement using an e-cigarette – could be a better way than Champix alone to help people with drug and alcohol addictions and/or mental health conditions quit smoking.
We plan to recruit around 500 people into the study over a 15 month period (from May 2017 to Aug 2018). This study has two parts which we call “screening” (2 weeks) and “trial” (6 months).
Screening (2 weeks)
- At the start of the study, participants will be asked to meet with a researcher at the CADS or CMHS clinic to talk about the study and sign a consent form about taking part to see if Champix can help you quit smoking. The researcher will ask some questions about the participant’s smoking.
- Participants will receive a prescription for Champix which they can pick up from a pharmacy free of charge.
- Champix is to be taken every day for 2 weeks as prescribed as the participant tries to quit smoking.
- A researcher will call the participant once over the two week period to provide advice and support about quitting.
- After two weeks, participants will be called again by the researcher. The researcher will ask again some questions about the participant’s smoking.
- If people have quit smoking or have cut down the number of cigarettes they smoke by half or more from the amount they smoked at the start of the two week period, and they still wish to continue the treatment, they will continue with Champix and be referred to local cessation services. They will no longer be included in the STATUS study.
Trial (6 months)
People who have not quit smoking and have not cut down the number of cigarettes they smoke by half or more from the amount they smoked at the start of the two week period will be randomly allocated (like the toss of a coin) to receive one of the following treatments to use over the following 10 weeks:
- Champix alone
- Champix plus e-cigarette with nicotine
- A researcher will call the participant six times over the first six weeks to provide advice and support about quitting.
- At 6, 12 and 24 weeks after being allocated to the different study groups, a researcher will ask the participant about their smoking and health.
- At 24 weeks, if the participant reports they have quit smoking the researcher will do a breath test (a “carbon monoxide” test) to see how effective the body is in clearing the tobacco smoke from the body. The test will take less than 3 minutes to do and does not hurt or cause any harm.
Interested in taking part? More detail about the process is provided in the Participant Information Sheet.
We have put in place 2 videos that you may find useful:
This short video provides an introduction on how to use the AIO D16 e-cigarette
This short video will help you with any problems you may be experiencing in using your AIO D16 e-cigarette