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N/A N=158 Randomized Double-blind Treatment

Innovative Digital Therapeutic for Smoking Cessation

Smoking Cessation · Nicotine Addiction · Drug Addiction · Drug Dependence · Tobacco Dependence

Enrolled (actual)
158
Serious AEs
0.6%
Results posted
Jun 2022
Primary outcome: Primary: 30-Day Sustained Abstinence From Smoking — 69; 66; 10; 13 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CT-101-M (Device); QuitGuide (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
My Digital Study
Primary completion
Mar 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
30-Day Sustained Abstinence From Smoking
69; 66; 10; 13
SECONDARY
Feasibility of Biochemical Verification of Smoking Cessation
9.766; 8.609
SECONDARY
NRT and Smoking Cessation Pharmacotherapy Use
10; 15; 56; 41; 13; 23

Summary

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

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

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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03694327). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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