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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02134509
Other study ID # 1301011337
Secondary ID 2K12DA000167-26
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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