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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA237004 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Chicago | OTHER |
| University of Utah | OTHER |
| George Washington University | OTHER |
| National Cancer Institute (NCI) |
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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.
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Addiction Treatment | Behavioral | Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 24 weeks after the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Home Mindfulness Practice (Number of Days Per Week) | Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome) | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment |
| Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS]) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire A Spears, Ph.D | Georgia State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30303 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27213492 | Background | 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. | |
| 35916707 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 8 weeks after the start of treatment |
|
24 weeks
Adverse events were assessed via regular check-in calls with participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully | Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, iQuit Mindfully text messages, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe disorientation (unrelated to study intervention) | Psychiatric disorders | Non-systematic Assessment | Participant was disoriented, likely due to substances consumed prior to study visit. Unrelated to study intervention. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild side effects of nicotine replacement therapy | Product Issues | Systematic Assessment | Mild side effects of nicotine replacement therapy (e.g., itching, upset stomach) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Claire Spears | Georgia State University | 404-413-9335 | cspears@gsu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2021 | Jul 13, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 3, 2024 | Feb 7, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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| ID | Term |
|---|---|
| D000095488 | Nicotine Replacement Therapy |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| NIH |
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| 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. |
|
| 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. |
|
|
| Nicotine Replacement Therapy | Drug | 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 | Behavioral | 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 | Behavioral | 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. |
|
|
Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; MAAS ranges 1-6) |
| 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 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) | 8 weeks after treatment |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Cigarettes smoked per day at baseline | Mean | Standard Deviation | Number of cigarettes per day |
|
| OG002 | Mindfulness-based Addiction Treatment (MBAT) | Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team. |
| OG003 | Usual Care | Participants in the usual care condition are provided with nicotine replacement therapy (NRT) and self-help materials, in addition to regular check-in calls from the research team. |
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 12 weeks after the start of treatment |
|
|
|
| Primary | 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 | Posted | Count of Participants | Participants | 24 weeks after the start of treatment |
|
|
|
| Secondary | Home Mindfulness Practice (Number of Days Per Week) | Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS]) | Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; MAAS ranges 1-6) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | 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) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | Self-compassion (Self-Compassion Scale-Short Form [SCS-SF]) | Self-reported self-compassion (questionnaire; higher frequency means better outcome; SCS-SF ranges 1-5) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | Stress (Perceived Stress Scale [PSS]) | Self-reported stress (questionnaire; lower scores mean better outcome; PSS ranges 0-40) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | 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) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | 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) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | 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) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | 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) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | Social Support (Multidimensional Scale of Perceived Social Support; Higher Scores Mean Better Outcome; Scores Range 1-7) | Self-reported perceived social support (questionnaire) | Not Posted | During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment | Participants |
| Secondary | 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) | Not Posted | 8 weeks after treatment | Participants |
| 0 |
| 141 |
| 0 |
| 141 |
| 7 |
| 141 |
| EG001 | iQuit Mindfully | Participants receive iQuit Mindfully text messages, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team. | 0 | 146 | 1 | 146 | 12 | 146 |
| EG002 | Mindfulness-based Addiction Treatment (MBAT) | Participants receive virtual group counseling based on the Mindfulness-Based Addiction Treatment (MBAT) group protocol, nicotine replacement therapy (NRT), and self-help materials in addition to regular check-in calls from the research team. | 2 | 147 | 0 | 147 | 12 | 147 |
| EG003 | Usual Care | Participants in the usual care condition are provided with nicotine replacement therapy (NRT) and self-help materials, in addition to regular check-in calls from the research team. | 0 | 70 | 0 | 70 | 8 | 70 |
|
|
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