N/A
N=158
Innovative Digital Therapeutic for Smoking Cessation
Smoking Cessation · Nicotine Addiction · Drug Addiction · Drug Dependence · Tobacco Dependence
Bottom Line
View on ClinicalTrials.gov: NCT03694327 ↗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
| Outcome | Result | p-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)
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.