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RCT for AI-based behavioral therapy application for smoking cessation

RCT for AI-based behavioral therapy application for smoking cessation - EILA4UKSH

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028466
Enrollment
144
Registered
2022-03-10
Start date
2022-05-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

F17

Interventions

Group 1: use of EILA-App to stop smoking Group 2: waiting group receiving a short consultation for nicotine replacement therapy. Change to arm 1 possible after 12 weeks

Sponsors

UKSH Lübeck Medizinische Klinik III
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - age >=18 years old - >= 3 points in Fagerström test or consumption of at least 10 cigarettes per day - wish to stop smoking - available mobile phone to install the application

Exclusion criteria

Exclusion criteria: - age <18 years old - proved addiction to other psychoactive substances - non-smoker - Capacity for consent lacking - no smartphone or missing opportunity to use application

Design outcomes

Primary

MeasureTime frame
both arms: being smoke-free after 3 months with negative test of cotinine in urin

Secondary

MeasureTime frame
- both arms: being smoke-free after 1 and 3 months with negative test of cotinine in urin - being smoke-free via self declaration after 1,3,6,12 months - adherence to therapy with EILA-App via self-declaration after 1,3,6,12 months - change of weight or Body-Mass-Index - change of lung function of the small airways - change of 22 hemodynamic parameters - craving/desire to smoke via visual analogue scale

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026