Drug Addiction, Drug Dependence, Nicotine Addiction, Smoking Cessation, Substance Use Disorder, Tobacco Dependence, Tobacco Smoking, Tobacco Use Disorder
Conditions
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.
Interventions
DEVICECT-101-M
Mobile Application
DEVICEQuitGuide
Mobile Application
Sponsors
My Digital Study
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-Day Sustained Abstinence From Smoking | Upon completion of 8-week period | Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Biochemical Verification of Smoking Cessation | Upon completion of 8-week period | Confirmation with the remote CO assessment was conducted to assess concordance between self-report and remote CO assessment results. Abstinence as per the CO assessment was defined as an iCO reading of fewer than 7ppm exhaled CO. |
| NRT and Smoking Cessation Pharmacotherapy Use | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment A Mobile Application (CT-101-M) Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
CT-101-M (Mobile Application): A reduced-functionality minimal viable product (MVP) version of Clickotine (CT-101). | 79 |
| Treatment B Mobile Application (QuitGuide) Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application | 79 |
| Total | 158 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 13 | 23 |
Baseline characteristics
| Characteristic | Total | Treatment B Mobile Application (QuitGuide) | Treatment A Mobile Application (CT-101-M) |
|---|---|---|---|
| Age, Customized 18-39 years | 119 Participants | 59 Participants | 60 Participants |
| Age, Customized 40-59 years | 37 Participants | 19 Participants | 18 Participants |
| Age, Customized 60+ years | 2 Participants | 1 Participants | 1 Participants |
| Education, Categorical > High School | 106 participants | 54 participants | 52 participants |
| Education, Categorical High School | 23 participants | 13 participants | 10 participants |
| Education, Categorical < HS or GED | 29 participants | 12 participants | 17 participants |
| Fagerstrom Test for Nicotine Dependence 0-3 | 40 Participants | 19 Participants | 21 Participants |
| Fagerstrom Test for Nicotine Dependence 4-7 | 100 Participants | 52 Participants | 48 Participants |
| Fagerstrom Test for Nicotine Dependence 8+ | 18 Participants | 8 Participants | 10 Participants |
| Family Size, Categorical 0-2 | 63 Participants | 32 Participants | 31 Participants |
| Family Size, Categorical 3-5 | 87 Participants | 40 Participants | 47 Participants |
| Family Size, Categorical 6+ | 8 Participants | 7 Participants | 1 Participants |
| Income Range, Categorical $20,000 to $55,000 | 76 Participants | 38 Participants | 38 Participants |
| Income Range, Categorical $55,000 to $100,000 | 28 Participants | 13 Participants | 15 Participants |
| Income Range, Categorical Less than $20,000 | 37 Participants | 21 Participants | 16 Participants |
| Income Range, Categorical Over $100,000 | 17 Participants | 7 Participants | 10 Participants |
| Internet Frequency, Categorical A few times per day | 4 Participants | 1 Participants | 3 Participants |
| Internet Frequency, Categorical At least once per day but less than several times | 7 Participants | 4 Participants | 3 Participants |
| Internet Frequency, Categorical At least several times per day | 65 Participants | 33 Participants | 32 Participants |
| Internet Frequency, Categorical Several times per day | 82 Participants | 41 Participants | 41 Participants |
| Money Spent on Cigarettes (Per Month) $16 to $30 | 50 Participants | 23 Participants | 27 Participants |
| Money Spent on Cigarettes (Per Month) $31 to $50 | 66 Participants | 33 Participants | 33 Participants |
| Money Spent on Cigarettes (Per Month) Less than $15 | 13 Participants | 9 Participants | 4 Participants |
| Money Spent on Cigarettes (Per Month) More than $50 | 29 Participants | 14 Participants | 15 Participants |
| Prior Quit Attempts 0 | 10 Participants | 5 Participants | 5 Participants |
| Prior Quit Attempts 1 | 31 Participants | 19 Participants | 12 Participants |
| Prior Quit Attempts 2 | 36 Participants | 20 Participants | 16 Participants |
| Prior Quit Attempts 3 | 28 Participants | 11 Participants | 17 Participants |
| Prior Quit Attempts 4 | 18 Participants | 12 Participants | 6 Participants |
| Prior Quit Attempts 5 | 16 Participants | 4 Participants | 12 Participants |
| Prior Quit Attempts N/A | 19 Participants | 8 Participants | 11 Participants |
| Quit Duration 1 month to 6 months | 45 Participants | 22 Participants | 23 Participants |
| Quit Duration 1 week to 1 month | 35 Participants | 17 Participants | 18 Participants |
| Quit Duration 6 months to 1 year | 28 Participants | 13 Participants | 15 Participants |
| Quit Duration Less than a week | 32 Participants | 19 Participants | 13 Participants |
| Quit Duration More than 1 year | 13 Participants | 6 Participants | 7 Participants |
| Quit Duration N/A | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized All Other Races | 34 Participants | 14 Participants | 20 Participants |
| Race/Ethnicity, Customized White | 124 Participants | 65 Participants | 59 Participants |
| Region of Enrollment United States | 158 Participants | 79 Participants | 79 Participants |
| Sex: Female, Male Female | 107 Participants | 55 Participants | 52 Participants |
| Sex: Female, Male Male | 51 Participants | 24 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 79 |
| other Total, other adverse events | 11 / 79 | 5 / 79 |
| serious Total, serious adverse events | 0 / 79 | 1 / 79 |
Outcome results
Primary
30-Day Sustained Abstinence From Smoking
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
Time frame: Upon completion of 8-week period
Population: The study population was randomized 1:1 across Treatment A (CT-101-M) and Treatment B (QuitGuide). The population enrolled was US only, male or female, ages 18 to 65, and smoke at least 5 cigarettes per day with an interest in quitting smoking within the next 30 days. Participants enrolled had not used Clickotine or QuitGuide; and were not using an NRT at the time of enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A Mobile Application (CT-101-M) | 30-Day Sustained Abstinence From Smoking | Reported Smoking in the Last 30 Days | 69 Participants |
| Treatment A Mobile Application (CT-101-M) | 30-Day Sustained Abstinence From Smoking | Reported Not Smoking in the Last 30 Days | 10 Participants |
| Treatment B Mobile Application (QuitGuide) | 30-Day Sustained Abstinence From Smoking | Reported Smoking in the Last 30 Days | 66 Participants |
| Treatment B Mobile Application (QuitGuide) | 30-Day Sustained Abstinence From Smoking | Reported Not Smoking in the Last 30 Days | 13 Participants |
Secondary
Feasibility of Biochemical Verification of Smoking Cessation
Confirmation with the remote CO assessment was conducted to assess concordance between self-report and remote CO assessment results. Abstinence as per the CO assessment was defined as an iCO reading of fewer than 7ppm exhaled CO.
Time frame: Upon completion of 8-week period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment A Mobile Application (CT-101-M) | Feasibility of Biochemical Verification of Smoking Cessation | 9.766 PPM | Standard Deviation 11.099 |
| Treatment B Mobile Application (QuitGuide) | Feasibility of Biochemical Verification of Smoking Cessation | 8.609 PPM | Standard Deviation 9.448 |
Secondary
NRT and Smoking Cessation Pharmacotherapy Use
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.
Time frame: Upon completion of 8-week period
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A Mobile Application (CT-101-M) | NRT and Smoking Cessation Pharmacotherapy Use | Used NRT (or other pharmaceutical quit aids) | 10 Participants |
| Treatment A Mobile Application (CT-101-M) | NRT and Smoking Cessation Pharmacotherapy Use | Did not Use NRT (or other pharmaceutical quit aids) | 56 Participants |
| Treatment A Mobile Application (CT-101-M) | NRT and Smoking Cessation Pharmacotherapy Use | Not Reported | 13 Participants |
| Treatment B Mobile Application (QuitGuide) | NRT and Smoking Cessation Pharmacotherapy Use | Used NRT (or other pharmaceutical quit aids) | 15 Participants |
| Treatment B Mobile Application (QuitGuide) | NRT and Smoking Cessation Pharmacotherapy Use | Did not Use NRT (or other pharmaceutical quit aids) | 41 Participants |
| Treatment B Mobile Application (QuitGuide) | NRT and Smoking Cessation Pharmacotherapy Use | Not Reported | 23 Participants |