Study of effectiveness of a smartphone app for stopping smoking focused on use of nicotine replacement therapy

Not Applicable

• Conditions: Cigarette smoking; Mental and Behavioural Disorders; Mental and behavioural disorders due to use of tobacco

• Registration Number: ISRCTN33423896
• Lead Sponsor: niversity College London

Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31477166 (added 04/09/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-22
• Study Completion: 2016-05-01
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Currently living in the UK
2. 18 years or older
3. A daily smoker (at least 10 cigarettes/day)
4. Purchased at least one nicotine replacement therapy product available in the UK (i.e., patches, gums, lozenges, microtabs, nasal or mouth spray, inhalator, or oral strips) over the counter
5. Interested to quit smoking completely (not just to cut down)
6. Has regular access to a relevant smartphone device (iOS) with access to the internet
7. Download and try using the suggested app to help them quit
8. Agree to be contacted via the app, e-mail or telephone at 8 weeks and 7 months after the registration
9. Agree to take part in testing of saliva samples, if invited.
10. Have no contraindications for NRT use (determined by the participants, for example in consultation with the pharmacist)
11. Not currently pregnant or breastfeeding

Participants also have to provide informed consent to participate in the study, accept the End User Licence Agreement & Privacy Policy, and complete the registration into the trial via the app.

Exclusion Criteria

1. Does not meet inclusion criteria
2. Only data from the first registration with the app will be included
3. Obtains NRT on prescription

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The primary outcome will be self-report of not smoking in the 4 weeks prior to the follow up scheduled for 8 weeks since registration, and biochemically verified by saliva cotinine level of <15 ng/mL, or by a saliva anabasine level of <1 ng/ml among those reporting using nicotine replacement therapy or electronic cigarettes.<br><br> Participants lost to follow up will be presumed to have resumed smoking.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Self-reported abstinence rates during the 4 weeks prior to the follow-up scheduled for 8 weeks after registration (complete abstinence, and rates of smoking 5 cigarettes or less)<br> 2. Self-reported use of nicotine replacement therapy since the registration, assessed at 8-week follow-up<br> 3. Self-reported use of other cessation medications and support at 8-week follow-up<br> 4. Satisfaction ratings of the intervention at 8-week follow-up<br> 5. Quantitative indices of app use (e.g., number of times the app was opened)<br> 6. Self-reported criteria required for the Russell Standard (RS6): self-reported continuous 6-month abstinence assessed at 7-month follow-up, defined as having no more than 5 cigarettes in the past 6 months and no cigarettes in the previous week<br> 7. Self-reported 7-day point-prevalence abstinence assessed at 7-month follow-up.<br>