Pragmatic Clinical Trial to Demonstrate Positive Healthcare Effects of the Digital Health Application Eila® as a Means to Treat Nicotine Addiction (Protocol Number X9001304)
- Conditions
- F17Mental and behavioural disorders due to use of tobacco
- Registration Number
- DRKS00027031
- Lead Sponsor
- Pfizer Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1000
1. Participants are at least 18 years old.
2. Participants are nicotine-dependent (in accordance with ICD-10 F17.2); i.e., they smoke at least one cigarette per day
3. Participants are willing to stop smoking.
4. Participants have an Eila®-compatible device at their disposition.
5. Participants have a valid private email address.
6. Participants are willing to use the app Eila® independently on a regular basis.
7. Participants have a primary residence in the Federal Republic of Germany.
Medical Conditions:
1. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
Prior/Concurrent Clinical Study Experience:
2. Participants were administered and/or are still using an investigational drug to treat nicotine addiction within 30 days prior to inclusion in this study.
3. Participants have received and/or are still using a software medical device to treat nicotine dependence prior to inclusion in this study.
Other Exclusions:
4. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
5. Participants do not have sufficient knowledge of the German language necessary to participate in the study.
6. Participants work 24h shifts (e.g., ambulance service, fire department) which prevent continuous participation in the study.
7. Participants are not willing to answer questions related to the study on a weekly basis over a period of 25 weeks.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 7-day point-prevalence of smoking abstinence at week 25
- Secondary Outcome Measures
Name Time Method 1.Reduction of nicotine dependence symptoms due to smoking (measured by the FTCD score)<br>2.Prolonged Abstinence from smoking (analysed using generalized linear mixed models)<br>3.Cessation of Smoking: Proportion of participants experiencing at least one cessation (i.e.,<br>non-smoking for at least 4 weeks) <br>4.Nicotine Withdrawal symptoms (measured by the Minnesota Tobacco Withdrawal Scale score)<br>5.Cigarette Consumption: derived from the number of consumed cigarettes during the last week<br>6.Time to Minor/Major Relapse: measured as time from quitting smoking to the occurrence of a minor/major relapse during the 25 weeks<br>7.Well-being: measured by the WHO-5 score<br>8.Cotinine level: cotinine levels in urine<br>9. Presence of depressed mood and generalized anxiety: measured by PHQ-4<br>