Smartphone Application for Smoking Cessation

Smoking Clinical Trial

Official title:

Smartphone Application for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134509
• Other study ID #: 1301011337
• Secondary ID: 2K12DA000167-26
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: January 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effectiveness of a smartphone application for smoking cessation in smokers ages 18 to 65 years.

Description:

In this randomized control trial, subjects will be randomly assigned to receive one of two treatments: (1) a standard smartphone application to support smokers working to become quit-free, or (2) the tested intervention, an app that trains behavioral strategies for smoking cessation. The primary endpoint of interest will be 1-week point prevalence abstinence at end of treatment, and at 3 and 6 months follow-up for individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 511
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Smoke 5+ cigarettes/day

• < 3 months abstinence in the past year

• Have a smartphone

• Score greater than or equal to 8 of 10 on the Contemplation Ladder (Biener & Abrams, 1991)

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Experimental App
It is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies 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
• Active Comparator App
It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	American Heart Association, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence abstinence at 6 months	Subjects will be assessed for smoking abstinence at a 6-month follow-up.	6 months after beginning treatment
Secondary	Point prevalence abstinence at 3 months	Subjects will be assessed for smoking abstinence at a 3-month follow-up.	3 months after beginning treatment