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Randomised, multicentre, controlled, double-blind, prospective study to evaluate the superiority of the Smoke Free App compared to standard therapy in dependent smokers

Randomised, multicentre, controlled, double-blind, prospective study to evaluate the superiority of the Smoke Free App compared to standard therapy in dependent smokers - RAUCHFREI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00031140
Enrollment
1442
Registered
2023-02-02
Start date
2023-08-03
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 the Smoke Free app in combination with a brief advice (smoking cessation advice according to the ABC strategy). Group 2: Use of an app with reduced functions in combination with a bri

Sponsors

Smoke Free 23 GmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: - diagnosed tobacco dependence according to ICD-10 GM F17.2 - intention to stop smoking - end device to use the app - willingness to participate in the study - willingness not to use any other app for smoking cessation for the duration of the study - resident (primary residence) in the Federal Republic of Germany - valid private e-mail address, postal address and telephone number - sufficient German language skills

Exclusion criteria

Exclusion criteria: - concurrent alcohol or drug dependence. - acute symptomatic psychiatric disorder or suicide risk. - severe cognitive impairment - dementia - acute concomitant illness at the time of the individual start of the study requiring hospitalisation - insufficient German language skills - living with a person who also uses the Smoke Free app - use of the Smoke Free app in the past 12 months

Design outcomes

Primary

MeasureTime frame
Self-reported 7-day point prevalence of smoking abstinence at 6-month follow-up.

Secondary

MeasureTime frame
1) Validated (cotinine test) 7-day point prevalence of smoking abstinence at 6-month follow-up. 2) Sustained abstinence over all measurement points

Countries

Germany

Contacts

Public ContactCaroline Schmidt-Lucke

MEDIACC GmbH

info@mediacc.de+49 30 521 044 80

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 21, 2026