Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification

My Digital Study1 site in 1 country158 target enrollmentOctober 24, 2018

ConditionsSmoking Cessation Nicotine Addiction Drug Addiction Drug Dependence Tobacco Dependence Tobacco Use Disorder Substance Use Disorder Tobacco Smoking

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Smoking Cessation
Sponsor: My Digital Study
Enrollment: 158
Locations: 1
Primary Endpoint: 30-Day Sustained Abstinence From Smoking
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is comparing the efficacy of two smoking cessation apps.

Detailed Description

Given that tobacco smoking is the leading cause of preventable death in the US, the development of effective cessation programs is critical; mobile phone applications represent a novel, accessible platform for helping smokers quit. This research project seeks to compare the efficacy of two smoking cessation apps. In a blinded, randomized, controlled study, current smokers motivated to quit will use a smoking cessation app for 8 weeks.

Registry

clinicaltrials.gov

Start Date

October 24, 2018

End Date

March 14, 2019

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

My Digital Study

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female age 18 to 65
•Fluent in written and spoken English (confirmed by ability to read and comprehend Informed Consent Form)
•Lives in the United States
•Smokes at least 5 cigarettes daily
•Is interested in quitting in the next 30 days
•The participant owns and has access to an iPhone with iOS 9 or greater capabilities, or an Android with OS 7 or greater capabilities
•The participant is willing and able to receive SMS text messages on their smartphone
•The participant is willing and able to receive email messages.
•Ability to confirm download of installed treatment arm app via telephone on randomization date.
•One half of the study sample will be recruited from the general population of smokers via social media advertisements

Exclusion Criteria

•Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention
•Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Outcomes

Primary Outcomes

30-Day Sustained Abstinence From Smoking

Time Frame: Upon completion of 8-week period

Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.

Secondary Outcomes

Feasibility of Biochemical Verification of Smoking Cessation(Upon completion of 8-week period)
NRT and Smoking Cessation Pharmacotherapy Use(Upon completion of 8-week period)