Innovative Digital Therapeutic for Smoking Cessation

NCT03694327 | Completed Results DMC FDA Device

• 1 other identifier: CT-101-002
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 30-Day Sustained Abstinence From Smoking

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

  Upon completion of 8-week period

Secondary Outcomes (2)

• 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

Study Arms (2)

Treatment A Mobile Application

EXPERIMENTAL

Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.

Device: CT-101-M

Treatment B Mobile Application

ACTIVE COMPARATOR

Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.

Device: QuitGuide

Interventions

CT-101-M DEVICE

Mobile Application

Treatment A Mobile Application

QuitGuide DEVICE

Mobile Application

Treatment B Mobile Application

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• One half of the study sample will be recruited via mail form a Magellan Behavioral Health value-based care network

You may not qualify if:

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

Sponsors & Collaborators

• My Digital Study: lead

Study Sites (1)

My Digital Study

New York, New York, 10013, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Tobacco Use Disorder; Substance-Related Disorders; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Chemically-Induced Disorders; Mental Disorders; Smoking; Tobacco Use

Results Point of Contact

• Title: Alankar Gupta, VP, Medical Affairs & Clinical Development
• Organization: MyDigitalStudy

agupta@clicktherapeutics.com

862-485-9279

Study Officials

• Brian M Iacoviello, PhD

  My Digital Study

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: October 3, 2018
• Study Start: October 24, 2018
• Primary Completion: March 14, 2019
• Study Completion: March 14, 2019
• Last Updated: June 6, 2022
• Results First Posted: June 6, 2022

Record last verified: 2022-05

Locations

US (1)