Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Cigarette Smoking Clinical Trial

Official title:

Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04965181
• Other study ID #: R01CA237004
• Secondary ID: R01CA237004
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: Georgia State University
• Contact: Claire A Spears, Ph.D.
• Phone: 404-413-9335
• Email: cspears[@]gsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 cessation.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 485
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking

Intervention

Behavioral:
• 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.

Drug:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Georgia State University	Atlanta	Georgia

Sponsors (5)

Lead Sponsor	Collaborator
Georgia State University	George Washington University, National Cancer Institute (NCI), University of Chicago, University of Utah

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with confirmed smoking abstinence, 8 weeks	Self-report of not smoking in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm	8 weeks after the start of treatment
Primary	Number of participants with confirmed smoking abstinence, 12 weeks	Self-report of not smoking in the past 7 days (not even a puff), confirmed by expired carbon monoxide <6 ppm	12 weeks after the start of treatment
Primary	Number of participants with confirmed smoking abstinence, 24 weeks	Self-report of not smoking in the past 7 days (not even a puff), confirmed by saliva cotinine < 20 ng/ml	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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Secondary	Dispositional mindfulness (Mindful Attention Awareness Scale [MAAS])	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
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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Secondary	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
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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
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)	During 8 weeks of treatment; 8, 12 and 24 weeks after the start of treatment
Secondary	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
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)	8 weeks after treatment