Mindfulness-based Smoking Cessation Enhanced With Mobile Technology

NCT04965181 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 504

Last updated 2026-02-27

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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

Interventions

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).

BEHAVIORAL

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.

Sponsors & Collaborators

  • University of Chicago

    collaborator OTHER
  • University of Utah

    collaborator OTHER
  • George Washington University

    collaborator OTHER
  • National Cancer Institute (NCI)

    collaborator NIH
  • Georgia State University

    lead OTHER

Principal Investigators

  • Claire A Spears, Ph.D · Georgia State University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2025-01-09
Completion
2025-01-09

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04965181 on ClinicalTrials.gov