Mechanisms of Mindfulness for Smoking Cessation

• ClinicalTrials.gov Identifier: NCT02943499
• Recruitment Status: Completed
• First Posted: October 24, 2016
• Results First Posted: November 12, 2019
• Last Update Posted: November 19, 2019
• Sponsor: Brown University
• Collaborator: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Judson Brewer, Brown University

Tracking Information

• First Submitted Date: October 21, 2016
• First Posted Date: October 24, 2016
• Results First Submitted Date: October 22, 2019
• Results First Posted Date: November 12, 2019
• Last Update Posted Date: November 19, 2019
• Study Start Date: October 2016
• Actual Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 10, 2019)

Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal [ Time Frame: 1 month ]

BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping

• Original Primary Outcome Measures (submitted: October 21, 2016): Changes in brain activity after app-based mindfulness training [ Time Frame: 1 month ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mechanisms of Mindfulness for Smoking Cessation
• Official Title: Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.
• Brief Summary: The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Other
• Condition: Smoking Cessation

Intervention

• Behavioral: App/Training
  This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones
• Behavioral: App/Training
  It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.
• Device: Smartphone

Study Arms

• Active Comparator: Active Comparator App/Training
  This is a standard smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. Subjects will be encouraged to set a quit date of 3 weeks, to allow comparison to experimental arm quit date.
  Interventions:

  • Behavioral: App/Training
  • Device: Smartphone
• Experimental: Experimental App/Training
  This is a 3-week smartphone-based training program that trains mindfulness for smoking cessation by helping smokers self-monitor their smoking habits, recognize when and how often they smoke, identify triggers for smoking, and learn methods to become more mindful of triggers, to quit smoking with a target quit date of 3 weeks.
  Interventions:

  • Behavioral: App/Training
  • Device: Smartphone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 22, 2019): 80
• Original Estimated Enrollment (submitted: October 21, 2016): 260
• Actual Study Completion Date: August 2018
• Actual Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 21-65 years of age
• Smoke 10+ cigarettes/day
• < 3 months abstinence in the past year
• Have a smartphone; and motivated to quit smoking
• Score >18 of 20 on Action subscale of the Readiness to Change Questionnaire

Exclusion Criteria:

• Any usage of psychotropic medication: not on a stable dosage 6+ months
• Prior participation in a mindfulness course or regular meditation practice (>20 min/week)
• Serious psychiatric, cognitive, or medical disorder
• MRI contraindications
• Structural brain damage as well as other brain abnormalities revealed by the MRI
• Claustrophobia
• Not being fluent in English
• Recreational drug use
• Pregnant women
• History of a neurological disorder
• Current participation in a smoking study
• Adults unable to consent
• Prisoners

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02943499
• Other Study ID Numbers: 1R61AT009337-01( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Judson Brewer, Brown University
• Original Responsible Party: Judson Brewer, University of Massachusetts, Worcester, Principal Investigator
• Current Study Sponsor: Brown University
• Original Study Sponsor: University of Massachusetts, Worcester
• Collaborators: University of Massachusetts, Worcester
• Investigators: Not Provided
• PRS Account: Brown University
• Verification Date: November 2019