| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN80978588 |
| Date ISRCTN assigned | 12/06/2007 |
| Local reference number(s) | Protocol Version 1; G0601639 |
| Public title | Stop smoking with mobile phones |
| Scientific title |
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| Acronym | TXT2STOP |
| Disease/condition/study domain | Smoking |
| Study hypothesis | TXT2STOP is a study for a trial of mobile phone text messaging as an aid to support smoking cessation in people in the UK. The pilot study for this trial has been assigned to ISRCTN37111532 (see http://www.controlled-trials.com/ISRCTN37111532). |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Ethics approval received from the St Thomas' Hospital Research Ethics Committee on the 5th December 2006 (ref: 06/Q0702/169). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Aged 16 years and over 2. Currently smoking cigarettes daily and interested in quitting 3. Owner of a mobile phone and familiar with text messaging capabilities 4. Able to provide informed consent to participate in the study |
| Participants - exclusion criteria | No exclusion criteria. |
| Patient information material |
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| Anticipated start date | 30/03/2007 |
| Anticipated end date | 29/03/2010 |
| Status of trial | Ongoing |
| Target number of participants | 5800 |
| Interventions | The intervention group will be encouraged to set a quit date within 14 days of randomisation. Five messages per day will be sent in the first five weeks after randomisation. The control group will receive fortnightly messages on the most well know health dangers of smoking. |
| Primary outcome measure(s) | Self reported abstinence at six months post randomisation. Verified by salivary cotinine testing using a cut-off of 7 ng/ml of cotinine. |
| Secondary outcome measure(s) | 1. At four weeks: point prevalence of smoking (as per National Health Service standard reporting) 2. At six months: 2.1. 28-day continuous abstinence 2.2. Involvement in any vehicle crashes (this is the only rare adverse health effects of using a mobile phone) |
| Trial website | http://www.txt2stop.org |
| Sources of funding | Medical Research Council (UK) (Grant ref no.: G0601639) |
| Sponsor name | London School of Hygiene and Tropical Medicine (UK) |
| Sponsor details | c/o Penny Ireland Keppel Street London United Kingdom WCIE 7HT |
| Sponsor telephone | +44 (0)20 7927 2678 |
| Sponsor fax | +44 (0)20 7580 5636 |
| Sponsor email | Penny.Ireland@lshtm.ac.uk |
| Sponsor website | http://www.lshtm.ac.uk |
| Contact name | Dr Caroline Free |
| Contact details | Nutrition and Public Health Research Interventions Unit London School of Hygiene and Tropical Medicine Keppel Street London United Kingdom WCIE 7HT |
| Contact telephone | +44 (0)20 7958 8109 |
| Contact fax | +44 (0)20 7958 8111 |
| Contact email | Caroline.Free@lshtm.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN80978588 |
| Date last extracted from ISRCTN register | 17/04/2008 |