Cigarette SmokingNCT04965181
Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
A study testing Mindfulness-Based Addiction Treatment, Nicotine Replacement Therapy and Self-help materials in people with Cigarette Smoking, run by Georgia State University at 1 site in United States.
Trial summary
The purpose of this study is to: 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Mindfulness-Based Addiction Treatment, Nicotine Replacement Therapy and Self-help materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 18 years of age
- 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
Who cannot join
- contraindication for nicotine patch or nicotine lozenge
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to:
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.
Read the detailed description
This study is a 2 X 2 randomized controlled trial to investigate the effects of the iQuit Mindfully text messaging program, both as a standalone intervention and in combination with in-person counseling (Mindfulness-based Addiction Treatment; MBAT), compared to usual care. Participants will be randomized to one of four groups based on assignment to iQuit Mindfully text messages (yes/no) and in-person MBAT (yes/no):
- 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
- Cigarette Smoking
- Being tested
- Mindfulness-Based Addiction Treatment, Nicotine Replacement Therapy, Self-help materials, iQuit Mindfully
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Addiction TreatmentBehavioural
Also called MBAT
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 TherapyDrug
Also called Generic Nicotine Patch, Generic Nicotine Lozenge
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 materialsBehavioural
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 MindfullyBehavioural
Also called Mindfulness-based text messaging for smoking cessation
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | Experimental | 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. Receives: Behavioral: Mindfulness-Based Addiction Treatment; Drug: Nicotine Replacement Therapy; Behavioral: Self-help materials; Behavioral: iQuit Mindfully |
| iQuit Mindfully | Experimental | 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. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Self-help materials; Behavioral: iQuit Mindfully |
| Mindfulness-based Addiction Treatment (MBAT) | Experimental | 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. Receives: Behavioral: Mindfulness-Based Addiction Treatment; Drug: Nicotine Replacement Therapy; Behavioral: Self-help materials |
| Usual Care | Active comparator | 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. Receives: Drug: Nicotine Replacement Therapy; Behavioral: Self-help materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Confirmed Smoking Abstinence, 8 Weeks
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm
Measured: 8 weeks after the start of treatment
Number of Participants With Confirmed Smoking Abstinence, 12 Weeks
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm
Measured: 12 weeks after the start of treatment
Number of Participants With Confirmed Smoking Abstinence, 24 Weeks
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by carbon monoxide < 6ppm and saliva cotinine < 20 ng/ml
Measured: 24 weeks after the start of treatment
Secondary outcomes (11)
Home Mindfulness Practice (Number of Days Per Week)
Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS])
Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; MAAS ranges 1-6)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Dispositional Mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF])
Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; FFMQ-SF ranges 24-120)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Self-compassion (Self-Compassion Scale-Short Form [SCS-SF])
Self-reported self-compassion (questionnaire; higher frequency means better outcome; SCS-SF ranges 1-5)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Stress (Perceived Stress Scale [PSS])
Self-reported stress (questionnaire; lower scores mean better outcome; PSS ranges 0-40)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Emotions (Positive and Negative Affect Schedule [PANAS])
Self-reported positive and negative emotions (questionnaire; lower scores on PANAS-Negative Affect mean better outcome; higher scores on PANAS-Positive Affect mean better outcome; PANAS-Negative Affect and Positive Affect each range 10-50)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Craving and Withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS])
Self-reported craving and withdrawal (questionnaire; lower scores mean better outcome; subscale scores for each withdrawal symptom range 0-4)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Nicotine Dependence (Brief Wisconsin Dependence Motives Questionnaire [WISDM])
Self-reported nicotine dependence (questionnaire; lower scores mean better outcome; subscale scores for each aspect of dependence range 1-7)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Self-efficacy (Self-Efficacy Scale)
Self-reported self-efficacy to abstain from smoking (questionnaire; higher scores mean better outcome; subscale scores for managing positive affect, negative affect, and craving without smoking range 3-15)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Social Support (Multidimensional Scale of Perceived Social Support; Higher Scores Mean Better Outcome; Scores Range 1-7)
Self-reported perceived social support (questionnaire)
Measured: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Program Evaluation (Questionnaire Developed for This Study to Evaluate Participants' Perceptions of the Helpfulness of Intervention Components, the Extent to Which They Would Recommend the Program to Others, and Suggestions for Improvement)
Feedback about interventions and perceived benefits (questionnaire; for quantitative questions, higher scores mean better outcome; for questions about helpfulness and recommending to others, scores range 1-10; for perceived benefits of program, scores range 1-5)
Measured: 8 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Jul 2021
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chicago, University of Utah, George Washington University, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Claire Spears, Georgia State University
- Investigators
- Claire A Spears, Ph.D, Principal investigator, Georgia State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965181
- Sponsor's protocol ID
- R01CA237004
- Other IDs
- R01CA237004
- Status last verified
- Dec 2025
- First submitted
- 1 Jul 2021
- Last updated
- 27 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27213492Spears 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.
PubMed 35916707
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness-based Smoking Cessation Enhanced With Mobile Technology
- ClinicalTrials.gov ID
- NCT04965181
- Acronym / sponsor ID
- R01CA237004
- Conditions
- Cigarette Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Georgia State UniversityUniversity, hospital or other
- Collaborators
- University of Chicago, University of Utah, George Washington University, National Cancer Institute (NCI)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 16 Jul 2021 (actual)
- Results
- Posted 30 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to:
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
This study is a 2 X 2 randomized controlled trial to investigate the effects of the iQuit Mindfully text messaging program, both as a standalone intervention and in combination with in-person counseling (Mindfulness-based Addiction Treatment; MBAT), compared to usual care. Participants will be randomized to one of four groups based on assignment to iQuit Mindfully text messages (yes/no) and in-person MBAT (yes/no):
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | Experimental | Behavioral: Mindfulness-Based Addiction Treatment, Drug: Nicotine Replacement Therapy, Behavioral: Self-help materials, Behavioral: iQuit MindfullyParticipants 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. |
| iQuit Mindfully | Experimental | Drug: Nicotine Replacement Therapy, Behavioral: Self-help materials, Behavioral: iQuit MindfullyParticipants 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. |
| Mindfulness-based Addiction Treatment (MBAT) | Experimental | Behavioral: Mindfulness-Based Addiction Treatment, Drug: Nicotine Replacement Therapy, Behavioral: Self-help materialsParticipants 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. |
| Usual Care | Active comparator | Drug: Nicotine Replacement Therapy, Behavioral: Self-help materialsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age
- 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
Key exclusion criteria (7 listed)
- contraindication for nicotine patch or nicotine lozenge
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Addiction TreatmentAlso: MBATMindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation. | Behavioural | Mindfulness-based Addiction Treatment (MBAT), Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully |
| Nicotine Replacement TherapyAlso: Generic Nicotine Patch, Generic Nicotine LozengePatch 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. | Drug | Mindfulness-based Addiction Treatment (MBAT), Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully, Usual Care, iQuit Mindfully |
| Self-help materialsSelf-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). | Behavioural | Mindfulness-based Addiction Treatment (MBAT), Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully, Usual Care, iQuit Mindfully |
| iQuit MindfullyAlso: Mindfulness-based text messaging for smoking cessationiQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation. | Behavioural | Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully, iQuit Mindfully |
Primary outcome
Number of Participants With Confirmed Smoking Abstinence, 8 Weeks
Time frame: 8 weeks after the start of treatment
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm
Number of Participants With Confirmed Smoking Abstinence, 12 Weeks
Time frame: 12 weeks after the start of treatment
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm
Number of Participants With Confirmed Smoking Abstinence, 24 Weeks
Time frame: 24 weeks after the start of treatment
Self-report of not smoking any combustible tobacco products in the past 7 days (not even a puff), confirmed by carbon monoxide < 6ppm and saliva cotinine < 20 ng/ml
11 secondary outcomes
Home Mindfulness Practice (Number of Days Per Week)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Dispositional Mindfulness (Five Facet Mindfulness Questionnaire-Short Form [FFMQ-SF])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Self-compassion (Self-Compassion Scale-Short Form [SCS-SF])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Stress (Perceived Stress Scale [PSS])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Emotions (Positive and Negative Affect Schedule [PANAS])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Craving and Withdrawal (Wisconsin Smoking Withdrawal Scale [WSWS])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Nicotine Dependence (Brief Wisconsin Dependence Motives Questionnaire [WISDM])
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Self-efficacy (Self-Efficacy Scale)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Social Support (Multidimensional Scale of Perceived Social Support; Higher Scores Mean Better Outcome; Scores Range 1-7)
Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Program Evaluation (Questionnaire Developed for This Study to Evaluate Participants' Perceptions of the Helpfulness of Intervention Components, the Extent to Which They Would Recommend the Program to Others, and Suggestions for Improvement)
Time frame: 8 weeks after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27213492Vidrine 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.
- Derived from this study: PubMed 35916707Spears 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire A Spears, Ph.D principal investigator
Georgia State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Addiction Treatment, Nicotine Replacement Therapy and Self-help materials in people with Cigarette Smoking, run by Georgia State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Confirmed Smoking Abstinence, 8 Weeks (time frame: 8 weeks after the start of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965181, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.