iQuit Mindfully: Text Messaging for Smoking Cessation

NCT03029819 | Completed Results DMC

• 1 other identifier: K23AT008442
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate text messaging as a way to enhance mindfulness-based treatment for smoking cessation.

Conditions

Cigarette Smoking

Outcome Measures

Primary Outcomes (1)

• Smoking Abstinence

  Number of participants who abstained from smoking (based on self-reported 7-day abstinence, which is biochemically verified by expired carbon monoxide \<6 parts per million (ppm)

  End of Treatment (8 weeks)

Secondary Outcomes (3)

• Participant Engagement

  Over the 8-week treatment period

• Participant Ratings

  End of Treatment (8 weeks)

• Attrition

  End of treatment (8 weeks)

Other Outcomes (3)

• Number of Cigarettes Smoked Per Day

  End of treatment (8 weeks)

• Weekly Mindfulness Practice

  Throughout treatment period (8 weeks)

• Self-reported Mindfulness and Psychological Functioning

  End of treatment (8 weeks)

Study Arms (2)

Mindfulness-based Addiction Treatment (MBAT)

ACTIVE COMPARATOR

Nicotine patch; self-help guide; MBAT

Behavioral: Mindfulness-based Addiction Treatment; Behavioral: Self-Help guide; Drug: Nicotine Patch

iQuit Mindfully

EXPERIMENTAL

Nicotine patch; self-help guide; MBAT; text messaging

Behavioral: Mindfulness-based Addiction Treatment; Behavioral: iQuit Mindfully; Behavioral: Self-Help guide; Drug: Nicotine Patch

Interventions

Mindfulness-based Addiction Treatment BEHAVIORAL

Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).

Mindfulness-based Addiction Treatment (MBAT); 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

iQuit Mindfully

Self-Help guide BEHAVIORAL

Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).

Mindfulness-based Addiction Treatment (MBAT); iQuit Mindfully

Nicotine Patch DRUG

Patch therapy (beginning the week before quit day) for participants who smoke \>10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.

Also known as: Generic Nicotine Patch

Mindfulness-based Addiction Treatment (MBAT); iQuit Mindfully

Eligibility Criteria

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

You may qualify if:

• age 18-65 years
• current smoker with history of \>5 cigarettes/day for past year (and expired carbon monoxide \>6 parts per million \[ppm\])
• motivated to quit within next 30 days
• valid home address in the greater Atlanta, Georgia area
• functioning telephone number
• own a mobile phone with text messaging capacity
• can speak, read, and write in English
• at least a sixth-grade level of health literacy

You may not qualify if:

• contraindication for nicotine patch
• active substance abuse/dependence
• regular use of tobacco products other than cigarettes
• current use of tobacco cessation medications
• pregnancy or lactation
• household member enrolled in the study
• current diagnosis of schizophrenia or bipolar disorder, or use of antipsychotic medications
• clinically significant depressive symptoms

Sponsors & Collaborators

• Georgia State University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• University of Utah: collaborator
• The Catholic University of America: collaborator
• George Washington University: collaborator
• University of Chicago: collaborator

Study Sites (1)

Georgia State University

Atlanta, Georgia, 30303, United States

Location

Related Publications (3)

• 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

• Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A U.S. Public Health Service report. Am J Prev Med. 2008 Aug;35(2):158-76. doi: 10.1016/j.amepre.2008.04.009.

  PMID: 18617085 BACKGROUND

• Spears CA, Abroms LC, Glass CR, Hedeker D, Eriksen MP, Cottrell-Daniels C, Tran BQ, Wetter DW. Mindfulness-Based Smoking Cessation Enhanced With Mobile Technology (iQuit Mindfully): Pilot Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 24;7(6):e13059. doi: 10.2196/13059.

  PMID: 31237242 DERIVED

MeSH Terms

Conditions

Cigarette Smoking

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

• Title: Claire Spears
• Organization: Georgia State University School of Public Health

cspears@gsu.edu

4044139335

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 16, 2017
• First Posted: January 24, 2017
• Study Start: January 18, 2017
• Primary Completion: August 10, 2017
• Study Completion: October 3, 2017
• Last Updated: January 8, 2019
• Results First Posted: December 17, 2018

Record last verified: 2018-12

Locations

US (1)