Innovative Digital Therapeutic for Smoking Cessation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03694327|
Recruitment Status : Completed
First Posted : October 3, 2018
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation Nicotine Addiction Drug Addiction Drug Dependence Tobacco Dependence Tobacco Use Disorder Substance Use Disorder Tobacco Smoking||Device: CT-101-M Device: QuitGuide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||158 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification|
|Actual Study Start Date :||October 24, 2018|
|Actual Primary Completion Date :||March 14, 2019|
|Actual Study Completion Date :||March 14, 2019|
Experimental: Treatment A Mobile Application
Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
Active Comparator: Treatment B Mobile Application
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
- 30-Day Sustained Abstinence from Smoking [ Time Frame: Upon completion of 8-week period ]Self-reported Abstinence from smoking on the 8-Week Outcome Survey
- Feasibility of biochemical verification of smoking cessation [ Time Frame: Upon completion of 8-week period ]Concordance between self-reported abstinence and measurement of exhaled carbon monoxide (CO) of <7ppm at study outcome will be assessed.
- NRT and Smoking Cessation Pharmacotherapy use [ Time Frame: Upon completion of 8-week period ]Self-reported NRT and smoking cessation pharmacotherapy use will be acquired via the outcome survey. Cessation rates will be compared between those using/not using pharmacotherapy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03694327
|United States, New York|
|My Digital Study|
|New York, New York, United States, 10013|
|Principal Investigator:||Brian M Iacoviello, PhD||My Digital Study|