Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

NCT04965181 | Completed Results

• 1 other identifier: R01CA237004
• Study Type: interventional
• Target: 504
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (11)

• Home Mindfulness Practice (Number of Days Per Week)

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

• Dispositional Mindfulness (Mindful Attention Awareness Scale [MAAS])

  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])

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

• Self-compassion (Self-Compassion Scale-Short Form [SCS-SF])

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

• Stress (Perceived Stress Scale [PSS])

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

Study Arms (4)

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.

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.

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.

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.

Drug: Nicotine Replacement Therapy; Behavioral: Self-help materials

Interventions

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).

Mindfulness-based Addiction Treatment (MBAT); Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully; Usual Care; iQuit Mindfully

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.

Also known as: Mindfulness-based text messaging for smoking cessation

Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully; iQuit Mindfully

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.

Also known as: MBAT

Mindfulness-based Addiction Treatment (MBAT); Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully

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.

Also known as: Generic Nicotine Patch, Generic Nicotine Lozenge

Mindfulness-based Addiction Treatment (MBAT); Mindfulness-based Addiction Treatment (MBAT) + iQuit Mindfully; Usual Care; iQuit Mindfully

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Georgia State University: lead
• University of Chicago: collaborator
• University of Utah: collaborator
• George Washington University: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (2)

• 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.

  PMID: 27213492 BACKGROUND

• 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.

  PMID: 35916707 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Claire Spears
• Organization: Georgia State University

cspears@gsu.edu

404-413-9335

Study Officials

• Claire A Spears, Ph.D

  Georgia State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 16, 2021
• Study Start: July 1, 2021
• Primary Completion: January 9, 2025
• Study Completion: January 9, 2025
• Last Updated: February 27, 2026
• Results First Posted: December 30, 2025

Record last verified: 2025-12

Locations

US (1)