Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Thera… (NCT05763771) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Smartphone-delivered Scheduled Smoking With Compliance Facilitation as an Adjunct Cessation Therapy: a Feasibility Study
United States56 participantsStarted 2024-02-15
Plain-language summary
To collect user experience data for a smartphone app that is designed to help people reduce or quit smoking and to learn if the app, combined with nicotine patches, can help people quit smoking.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Age: 18 years old or older
* Smoking: an average of 10 or more cigarettes, little cigars, or cigarillos combined per day within the past 30 days preceding the phone screen
* Expired carbon monoxide (CO): \> 6 ppm
* Can install and run the study app on their Android smartphone, or agree to use the study smartphone loaned from the research team
* Agree to return the study smartphone if the participant loans one from the research team
* Willing to reduce smoking (Aim 1)
* Seeking smoking cessation treatment (Aim 2)
* Fluency in spoken and written English
* Agree to be treated via telehealth (live audio-video conference and phone) and to be contacted via text and/or email
* Provide informed consent and agree to all assessments and study procedures
* Willing to refrain from the use of other nicotine/tobacco products for the duration of the study
* Willing to refrain from the use of marijuana, prescription medications not prescribed to the participant, and illegal drugs
Exclusion Criteria:
* Taking psychotropic, anticonvulsive, or narcotic medication
* Meet criteria for a current major depressive episode or suicidality according to the PHQ (indicated by a score of 10 or higher).
* Involved in current and imminent (within the next 45 days) smoking cessation activity
* Women who are pregnant or breastfeeding
* Shares the same address as a currently enrolled participant
* Unwilling to use or allergic to nicotine patches (Aim 2)
* Considered by the investigator …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Application (App) Usability Questionnaire
Timeframe: through completion of study; an average of 1 year.