Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
NCT ID: NCT04965181
Last Updated: 2025-12-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
504 participants
INTERVENTIONAL
2021-07-01
2025-01-09
Brief Summary
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Aim I: Test the efficacy of a mindfulness-based text messaging program for smoking cessation ("iQuit Mindfully"), both as a standalone intervention and in combination with in-person counseling; and Aim II: Investigate the mechanisms through which mindfulness training impacts smoking cessation.
Detailed Description
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* Usual Care (self-help materials + nicotine patch and nicotine lozenge treatment)
* MBAT (8 weekly virtual MBAT sessions + self-help materials + nicotine patch and nicotine lozenge treatment)
* iQuit Mindfully (iQuit Mindfully text messages + self-help materials + nicotine patch and nicotine lozenge treatment)
* MBAT + iQuit Mindfully (8 weekly virtual MBAT sessions + iQuit Mindfully text messages + self-help materials + nicotine patch and nicotine lozenge treatment)
All study participants will receive self-help smoking cessation materials, including the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW). All study participants will also receive nicotine patches and lozenges. Assessments will occur at baseline and weeks 1, 3, 5, and 8. Follow-up assessments will occur at weeks 12 and 24.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully
Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.
Mindfulness-Based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.
Nicotine Replacement Therapy
Patch therapy (beginning quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches.
Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges.
Self-help materials
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW).
iQuit Mindfully
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
iQuit Mindfully
Participants will receive iQuit Mindfully text messages and nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.
Nicotine Replacement Therapy
Patch therapy (beginning quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches.
Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges.
Self-help materials
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW).
iQuit Mindfully
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Mindfulness-based Addiction Treatment (MBAT)
Participants will receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol and nicotine replacement therapy (NRT). MBAT consists of 8 weekly 2-hour sessions. NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.
Mindfulness-Based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.
Nicotine Replacement Therapy
Patch therapy (beginning quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches.
Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges.
Self-help materials
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW).
Usual Care
Participants in the usual care condition are provided with nicotine replacement therapy (NRT). NRT consists of 8 weeks of generic nicotine patches and nicotine lozenges. Participants who smoke \>10 cigarettes/day will receive 4 weeks of 21 mg patches, 2 weeks of 14 mg patches, and 2 weeks of 7 mg patches. Those who smoke less than 10 cigarettes/day will receive 4 weeks of 14 mg patches and 4 weeks of 7 mg patches. Participants who smoke their first cigarette within 30 minutes of waking will receive 8 weeks of 4mg mini lozenges (6-9 4mg mini lozenges per day). Those who smoke their first cigarette over 30 minutes of waking will receive 8 weeks of 2mg mini lozenges (6-9 2mg mini lozenges per day). Participants will also be given the National Cancer Institute "Clearing the Air" booklet and a referral to the Tobacco Cessation Quitline.
Nicotine Replacement Therapy
Patch therapy (beginning quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches.
Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges.
Self-help materials
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW).
Interventions
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Mindfulness-Based Addiction Treatment
Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.
Nicotine Replacement Therapy
Patch therapy (beginning quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches.
Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges.
Self-help materials
Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the "Clearing the Air" booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW).
iQuit Mindfully
iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* current smoker with history of \>3 cigarettes/day (and expired carbon monoxide \[CO\] \>6ppm)
* motivated to quit within next 30 days
* valid home address in the greater Atlanta, GA area
* functioning telephone number
* can speak, read, and write in English
Exclusion Criteria
* active substance abuse/dependence
* current suicidal ideation
* current use of tobacco cessation medications
* pregnancy, planning to become pregnant in the next 5 months, or lactation
* household member enrolled in the study
* enrolled in previous smoking cessation study based on mindfulness and/or text messaging at Georgia State University
18 Years
ALL
No
Sponsors
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University of Chicago
OTHER
University of Utah
OTHER
George Washington University
OTHER
National Cancer Institute (NCI)
NIH
Georgia State University
OTHER
Responsible Party
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Claire Spears
Associate Professor
Principal Investigators
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Claire A Spears, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Georgia State University
Locations
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Georgia State University
Atlanta, Georgia, United States
Countries
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References
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Vidrine JI, Spears CA, Heppner WL, Reitzel LR, Marcus MT, Cinciripini PM, Waters AJ, Li Y, Nguyen NT, Cao Y, Tindle HA, Fine M, Safranek LV, Wetter DW. Efficacy of mindfulness-based addiction treatment (MBAT) for smoking cessation and lapse recovery: A randomized clinical trial. J Consult Clin Psychol. 2016 Sep;84(9):824-838. doi: 10.1037/ccp0000117.
Spears CA, Mhende J, Hawkins C, Do VV, Hayat MJ, Eriksen MP, Hedeker D, Abroms LC, Wetter DW. Mindfulness-Based Smoking Cessation Delivered Through Telehealth and Text Messaging for Low-Income Smokers: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 1;11(8):e35688. doi: 10.2196/35688.
Provided Documents
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