Trial Outcomes & Findings for Innovative Digital Therapeutic for Smoking Cessation (NCT NCT03694327)
NCT ID: NCT03694327
Last Updated: 2022-06-06
Results Overview
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
158 participants
Primary outcome timeframe
Upon completion of 8-week period
Results posted on
2022-06-06
Participant Flow
Participant milestones
| Measure |
Treatment A Mobile Application
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).
|
Treatment B Mobile Application
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
Overall Study
STARTED
|
79
|
79
|
|
Overall Study
COMPLETED
|
66
|
56
|
|
Overall Study
NOT COMPLETED
|
13
|
23
|
Reasons for withdrawal
| Measure |
Treatment A Mobile Application
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).
|
Treatment B Mobile Application
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
23
|
Baseline Characteristics
Innovative Digital Therapeutic for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Treatment A Mobile Application (CT-101-M)
n=79 Participants
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).
|
Treatment B Mobile Application (QuitGuide)
n=79 Participants
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
18-39 years
|
60 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Age, Customized
40-59 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Customized
60+ years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
59 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
All Other Races
|
20 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
79 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Family Size, Categorical
0-2
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Family Size, Categorical
3-5
|
47 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Family Size, Categorical
6+
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education, Categorical
< HS or GED
|
17 participants
n=5 Participants
|
12 participants
n=7 Participants
|
29 participants
n=5 Participants
|
|
Education, Categorical
High School
|
10 participants
n=5 Participants
|
13 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Education, Categorical
> High School
|
52 participants
n=5 Participants
|
54 participants
n=7 Participants
|
106 participants
n=5 Participants
|
|
Income Range, Categorical
Less than $20,000
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Income Range, Categorical
$20,000 to $55,000
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Income Range, Categorical
$55,000 to $100,000
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Income Range, Categorical
Over $100,000
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Internet Frequency, Categorical
A few times per day
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Internet Frequency, Categorical
At least once per day but less than several times
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Internet Frequency, Categorical
At least several times per day
|
32 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Internet Frequency, Categorical
Several times per day
|
41 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
0-3
|
21 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
4-7
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Fagerstrom Test for Nicotine Dependence
8+
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Money Spent on Cigarettes (Per Month)
Less than $15
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Money Spent on Cigarettes (Per Month)
$16 to $30
|
27 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Money Spent on Cigarettes (Per Month)
$31 to $50
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Money Spent on Cigarettes (Per Month)
More than $50
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Quit Duration
Less than a week
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Quit Duration
1 week to 1 month
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Quit Duration
1 month to 6 months
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Quit Duration
6 months to 1 year
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Quit Duration
More than 1 year
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Quit Duration
N/A
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Prior Quit Attempts
0
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Prior Quit Attempts
1
|
12 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Prior Quit Attempts
2
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Prior Quit Attempts
3
|
17 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Prior Quit Attempts
4
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Prior Quit Attempts
5
|
12 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Prior Quit Attempts
N/A
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Upon completion of 8-week periodPopulation: 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
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
Outcome measures
| Measure |
Treatment A Mobile Application (CT-101-M)
n=79 Participants
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).
|
Treatment B Mobile Application (QuitGuide)
n=79 Participants
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
30-Day Sustained Abstinence From Smoking
Reported Smoking in the Last 30 Days
|
69 Participants
|
66 Participants
|
|
30-Day Sustained Abstinence From Smoking
Reported Not Smoking in the Last 30 Days
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Upon completion of 8-week periodConfirmation 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.
Outcome measures
| Measure |
Treatment A Mobile Application (CT-101-M)
n=47 Participants
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).
|
Treatment B Mobile Application (QuitGuide)
n=46 Participants
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
Feasibility of Biochemical Verification of Smoking Cessation
|
9.766 PPM
Standard Deviation 11.099
|
8.609 PPM
Standard Deviation 9.448
|
SECONDARY outcome
Timeframe: Upon completion of 8-week periodSelf-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.
Outcome measures
| Measure |
Treatment A Mobile Application (CT-101-M)
n=79 Participants
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).
|
Treatment B Mobile Application (QuitGuide)
n=79 Participants
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
NRT and Smoking Cessation Pharmacotherapy Use
Used NRT (or other pharmaceutical quit aids)
|
10 Participants
|
15 Participants
|
|
NRT and Smoking Cessation Pharmacotherapy Use
Did not Use NRT (or other pharmaceutical quit aids)
|
56 Participants
|
41 Participants
|
|
NRT and Smoking Cessation Pharmacotherapy Use
Not Reported
|
13 Participants
|
23 Participants
|
Adverse Events
Treatment A Mobile Application (CT-101-M)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Treatment B Mobile Application (QuitGuide)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment A Mobile Application (CT-101-M)
n=79 participants at risk
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).
|
Treatment B Mobile Application (QuitGuide)
n=79 participants at risk
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
Other adverse events
| Measure |
Treatment A Mobile Application (CT-101-M)
n=79 participants at risk
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).
|
Treatment B Mobile Application (QuitGuide)
n=79 participants at risk
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.
QuitGuide: Mobile Application
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection Viral NOS
|
3.8%
3/79 • Number of events 3 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
General disorders
Concussion with no loss of consciousness
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Fractured Coccyx
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Psychiatric disorders
Borderline Personality
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Gastrointestinal disorders
Acute Gastroenteritis
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Bronchitis
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Musculoskeletal and connective tissue disorders
Knee Osteoarthritis
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Upper Respiratory Tract Infection
|
2.5%
2/79 • Number of events 2 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
2.5%
2/79 • Number of events 2 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/79 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
1.3%
1/79 • Number of events 1 • AE collection occurred 8 weeks after participant began treatment.
Adverse event and serious adverse event definitions used are the same as clinilcaltrials.gov. Method of collection: Participants were instructed to contact the study coordinator via a study-specific e-mail and phone number in the event they experienced any adverse event during their participation in the study.
|
Additional Information
Alankar Gupta, VP, Medical Affairs & Clinical Development
MyDigitalStudy
Phone: 862-485-9279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place