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OpenTrials
Completed

NCT Number: NCT02943499

Mechanisms of Mindfulness for Smoking Cessation

The purpose of this study is to understand brain mechanisms of app-based mindfulness training in smokers ages 21 to 65 years.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App/Training

Behavioral

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

smartphone

Device

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Brown University

Other

Collaborators

  • University of Massachusetts, Worcester

Registry information

Official study title

Mechanisms of Mindfulness for Smoking Cessation: Optimizing Quantity and Quality.

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 24, 2016
Registry last updated
Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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