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Completed

NCT Number: NCT04965181

Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

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.

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Key information

Conditions

Cigarette Smoking Behavior Smoking Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Georgia State University

Atlanta, Georgia, 30303, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: MBAT

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.

Other names: Generic Nicotine Patch, Generic Nicotine Lozenge

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.

Other names: Mindfulness-based text messaging for smoking cessation

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

    Self-reported frequency of home mindfulness practice (questionnaire; higher frequency means better outcome)

  2. Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS])

    Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment

    Self-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; MAAS ranges 1-6)

  3. 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-reported dispositional mindfulness (questionnaire; higher frequency means better outcome; FFMQ-SF ranges 24-120)

  4. 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

    Self-reported self-compassion (questionnaire; higher frequency means better outcome; SCS-SF ranges 1-5)

  5. Stress (Perceived Stress Scale [PSS])

    Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment

    Self-reported stress (questionnaire; lower scores mean better outcome; PSS ranges 0-40)

  6. Emotions (Positive and Negative Affect Schedule [PANAS])

    Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment

    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)

  7. 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

    Self-reported craving and withdrawal (questionnaire; lower scores mean better outcome; subscale scores for each withdrawal symptom range 0-4)

  8. 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-reported nicotine dependence (questionnaire; lower scores mean better outcome; subscale scores for each aspect of dependence range 1-7)

  9. Self-efficacy (Self-Efficacy Scale)

    Time frame: During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment

    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)

  10. 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

    Self-reported perceived social support (questionnaire)

  11. 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

    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)

Sponsors and collaborators

Lead sponsor

Georgia State University

Other

Collaborators

  • George Washington University
  • National Cancer Institute (NCI)
  • University of Chicago
  • University of Utah

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 16, 2021
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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