An interventional study of Mindful Smoking and Sensor-Band Intervention and Smoking Cessation Information in Smoking Cessation, Cigarette Smoking and Tobacco Use, sponsored by University of Minnesota. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
This pilot randomized controlled trial will test the feasibility of a smoking cessation intervention using mindful smoking practice and a smartphone-based sensor-band among adults who regularly smoke cigarettes.
Participants will be randomized to either an intervention group or a control group. Participants in the intervention group will receive a one-on-one mindful smoking guidance session, instructions for using a smartphone-based sensor-band, a mindfulness practice video, and smoking cessation information. Participants in the control group will receive smoking cessation information. The intervention period will last 8 weeks, with assessments at baseline, 8 weeks, and 4 months after completion of the intervention.
The study will evaluate feasibility, preliminary smoking cessation outcomes, and physiologic parameters including heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.
Cigarette smoking is a leading preventable cause of morbidity and mortality and contributes to cancer, lung disease, health care costs, and reduced quality of life. Although many adults who smoke cigarettes attempt to quit, long-term cessation rates remain low. Mindfulness-based strategies may help people who smoke manage cravings by increasing awareness of present-moment thoughts, emotions, and physical sensations without automatically reacting by smoking.
This pilot randomized controlled trial will evaluate a smoking cessation intervention that combines mindful smoking practice with use of a smartphone-based sensor-band. The study will enroll 30 adults who regularly smoke cigarettes and are motivated to quit smoking or make a quit attempt. Participants will be randomly assigned to an intervention group or a control group, with approximately 15 participants in each group.
Participants in the intervention group will receive a one-hour, one-on-one, in-person mindful smoking guidance session from a certified mindfulness instructor. The session will teach participants to manage cravings mindfully using the RAIN method: Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video for home practice and in-person instruction from a research assistant on use of the smartphone-based sensor-band. During the 8-week self-management and intervention period, participants in the intervention group will be instructed to practice mindful smoking when they feel a craving to smoke. They will be asked to record their craving level, duration of mindful smoking practice, feelings after mindful smoking, heart rate at the time of craving, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.
Participants in the control group will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Control group participants will be asked to record their daily cigarette smoking activities.
Data will be collected at baseline, 8 weeks after the intervention begins, and 4 months after the intervention is completed. Feasibility will be assessed by recruitment rate, time to recruit the target sample, intervention uptake rate, attrition rate, and participant satisfaction. Preliminary effectiveness will be assessed by 8-week and 4-month smoking abstinence rates and smoking reduction. Smoking abstinence will be confirmed using exhaled carbon monoxide measurement. The study will also assess stress level, self-control and management level, mindfulness level, heart rate variation, skin temperature, resting heart rate, respiratory rate, and real-time heart rate during craving and mindful smoking practice.
1,581 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.
This study's planned enrollment of 30 is below the median of 164 across 1,423 interventional studies indexed under Smoking Cessation.
Browse Smoking Cessation studies →University of Minnesota is the lead sponsor of 1,216 studies on the registry; 197 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants in this arm will receive a one-hour, one-on-one mindful smoking guidance session from a certified mindfulness instructor, instruction on use of the smartphone-based sensor-band, a mindfulness practice video for home practice, and smoking cessation information. During the 8-week intervention period, participants will be instructed to practice mindful smoking when they feel a craving to smoke and to record craving level, duration of mindful smoking practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily cigarette smoking activities.
Behavioral: Mindful Smoking and Sensor-Band Intervention
Participants in this arm will receive smoking cessation information published by the American Lung Association, including printed smoking cessation materials. Participants will be asked to record their daily cigarette smoking activities in a paper notebook.
Behavioral: Smoking Cessation Information
The intervention includes a one-hour, one-on-one mindful smoking guidance session using the RAIN method, which includes Recognize, Accept, Investigate, and Note. Participants will also receive a mindfulness practice video and instructions for using a smartphone-based sensor-band. During the 8-week intervention period, participants will practice mindful smoking when they feel a craving to smoke and will record craving level, duration of practice, feelings after practice, heart rate at craving time, heart rate at the end of mindful smoking practice, and daily smoking activities.
Also known as: Quit With Sense
Participants will receive smoking cessation information published by the American Lung Association, including printed materials such as The Smoking Health Effects brochure and Top Tips for Quitting Smoking.
Recruitment rate
Recruitment rate will be measured as the proportion of eligible participants who agree to participate in the study.
Time frame: Baseline / recruitment period, up to 6 months
Time to recruit target sample
Time to recruit the target sample will be measured as the duration of time required to recruit the target sample size.
Time frame: Up to 6 months
Intervention uptake rate
Intervention uptake rate will be measured as the percentage of participants who complete the intervention.
Time frame: 8 weeks
Attrition rate
Attrition rate will be measured as the percentage of participants who drop out before completing the study.
Time frame: Up to 4 months after completion of the 8-week intervention
Client satisfaction
Client satisfaction will be assessed using the Satisfaction Feedback Questionnaire, adapted from the Client Satisfaction Questionnaire. It has 4 questions with ordinal level options. The value of the scare measurement ranges from 0 to 12. Higher score means a higher satisfaction level.
Time frame: 8 weeks
8-week smoking abstinence rate
Smoking abstinence at 8 weeks will be measured as the percentage of participants who quit smoking at the 8-week time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.
Time frame: 8 weeks
8-week smoking reduction
Smoking reduction at 8 weeks will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 8-week time point.
Time frame: Baseline to 8 weeks
4-month smoking abstinence rate
Smoking abstinence at 4 months after intervention completion will be measured as the percentage of participants who quit smoking at the 4-month follow-up time point. Abstinence will be confirmed by exhaled carbon monoxide measurement level of less than 8 ppm.
Time frame: 4 months after completion of the intervention
4-month smoking reduction
Smoking reduction at 4 months after intervention completion will be measured as the reduction in the mean number of cigarettes smoked per day from baseline to the 4-month follow-up time point.
Time frame: Baseline to 4 months after completion of the intervention
Stress level
Stress level will be assessed using the Perceived Stress Scale. It has 10 questions with ordinal level options. The value of the scare measurement ranges from 0 to 40. Higher score means a higher stress level.
Time frame: Baseline to 8 weeks
Self-control and management level
Self-control and management level will be assessed using the Self-control and Management Scale. It has 16 questions with ordinal level options. The value of the scare measurement ranges from 0 to 80. Higher score means a higher self-control and management level.
Time frame: Baseline to 8 weeks
Mindfulness level
Mindfulness level will be assessed using the Mindful Attention Awareness Scale. It has 15 questions with ordinal level options. The value of the scare measurement ranges from 0 to 75. Higher score means a higher mindful attention awareness level.
Time frame: Baseline to 8 weeks
Respiratory Rate Measured by Smartphone-Based Sensor-Band
Respiratory rate will be measured in breaths per minute using the smartphone-based sensor-band among intervention group participants.
Time frame: During the 8-week intervention period
Heart Rate Variability Measured by Smartphone-Based Sensor-Band
Physiologic parameters including respiratory rate, heart rate variation, skin temperature, and resting heart rate will be collected using the smartphone-based sensor-band among intervention group participants. Physiologic parameters including respiratory rate measured by breaths per minute, heart rate variation measured by milliseconds, skin temperature measured by Farehent degree, and resting heart rate measured by heart beats per minute, will be collected using the smartphone-based sensor-band among intervention group participants.
Time frame: During the 8-week intervention period
Skin Temperature Measured by Smartphone-Based Sensor-Band
Skin temperature will be measured in degrees Fahrenheit using the smartphone-based sensor-band among intervention group participants.
Time frame: During the 8-week intervention period
Resting Heart Rate Measured by Smartphone-Based Sensor-Band
Resting heart rate will be measured in beats per minute using the smartphone-based sensor-band among intervention group participants.
Time frame: During the 8-week intervention period
Heart rate during craving and mindful smoking practice
Real-time heart rate will be measured at the time of cigarette craving and at the end of mindful smoking practice among intervention group participants.
Time frame: During the 8-week intervention period
Start is estimated for Nov 2026; primary completion for Dec 2027, 13 months later.
Of 546 non-industry interventional studies with no phase under Smoking Cessation, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 13 months is below that.
Counting every sponsor, half of 563 studies reached it within 24 months; a quarter within 12 and three quarters within 44.
Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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