Mechanisms of Mindfulness for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943499
• Other study ID #: 1R61AT009337-01
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: August 2018

Study information

• Verified date: November 2019
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• 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
• 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

Locations

Country	Name	City	State
United States	University of Massachusetts, Worcester	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Blood Oxygen Level Dependent (BOLD) Signal	BOLD signal change will be measured by fMRI and analyzed using statistical parametric mapping	1 month