Innovative Digital Therapeutic for Smoking Cessation

• Sponsor: My Digital Study (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03694327
• Collaborator: (none)
• Enrollment: 158
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.6
• Patients Per Site Per Month: 34.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Smoking Cessation; Nicotine Addiction; Drug Addiction; Drug Dependence; Tobacco Dependence; Tobacco Use Disorder; Substance Use Disorder; Tobacco Smoking	Device: CT-101-M; Device: QuitGuide	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 158 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
• Actual Study Start Date: Oct 24, 2018
• Actual Primary Completion Date: Mar 14, 2019
• Actual Study Completion Date: Mar 14, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment A Mobile Application Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.	Device: CT-101-M; Mobile Application
Active Comparator: Treatment B Mobile Application Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.	Device: QuitGuide; Mobile Application

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	My Digital Study	New York	New York	United States	10013

Sponsors and Collaborators

• My Digital Study

Investigators

• Principal Investigator: Brian M Iacoviello, PhD, My Digital Study

Study Documents (Full-Text)

• Study Protocol - Mar 10, 2022
• Statistical Analysis Plan - Mar 10, 2022

More Information

Publications

None provided.

• Responsible Party: My Digital Study
• ClinicalTrials.gov Identifier: NCT03694327
• Other Study ID Numbers: CT-101-002
• First Posted: Oct 3, 2018
• Last Update Posted: Jun 6, 2022
• Last Verified: May 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Disease; Substance-Related Disorders; Tobacco Use Disorder; Behavior, Addictive

Study Results

Participant Flow

Arm/Group Title	Treatment A Mobile Application	Treatment B Mobile Application
Arm/Group Description	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 Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application
Period Title: Overall Study
STARTED	79	79
COMPLETED	66	56
NOT COMPLETED	13	23

Baseline Characteristics

Arm/Group Title	Treatment A Mobile Application (CT-101-M)	Treatment B Mobile Application (QuitGuide)	Total
Arm/Group Description	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 Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application	Total of all reporting groups
Overall Participants	79	79	158
Age, Customized (Count of Participants)
18-39 years	60 75.9%	59 74.7%	119 75.3%
40-59 years	18 22.8%	19 24.1%	37 23.4%
60+ years	1 1.3%	1 1.3%	2 1.3%
Sex: Female, Male (Count of Participants)
Female	52 65.8%	55 69.6%	107 67.7%
Male	27 34.2%	24 30.4%	51 32.3%
Race/Ethnicity, Customized (Count of Participants)
White	59 74.7%	65 82.3%	124 78.5%
All Other Races	20 25.3%	14 17.7%	34 21.5%
Region of Enrollment (Count of Participants)
United States	79 100%	79 100%	158 100%
Family Size, Categorical (Count of Participants)
0-2	31 39.2%	32 40.5%	63 39.9%
3-5	47 59.5%	40 50.6%	87 55.1%
6+	1 1.3%	7 8.9%	8 5.1%
Education, Categorical (participants) [Number]
< HS or GED	17 21.5%	12 15.2%	29 18.4%
High School	10 12.7%	13 16.5%	23 14.6%
> High School	52 65.8%	54 68.4%	106 67.1%
Income Range, Categorical (Count of Participants)
Less than $20,000	16 20.3%	21 26.6%	37 23.4%
$20,000 to $55,000	38 48.1%	38 48.1%	76 48.1%
$55,000 to $100,000	15 19%	13 16.5%	28 17.7%
Over $100,000	10 12.7%	7 8.9%	17 10.8%
Internet Frequency, Categorical (Count of Participants)
A few times per day	3 3.8%	1 1.3%	4 2.5%
At least once per day but less than several times	3 3.8%	4 5.1%	7 4.4%
At least several times per day	32 40.5%	33 41.8%	65 41.1%
Several times per day	41 51.9%	41 51.9%	82 51.9%
Fagerstrom Test for Nicotine Dependence (Count of Participants)
0-3	21 26.6%	19 24.1%	40 25.3%
4-7	48 60.8%	52 65.8%	100 63.3%
8+	10 12.7%	8 10.1%	18 11.4%
Money Spent on Cigarettes (Per Month) (Count of Participants)
Less than $15	4 5.1%	9 11.4%	13 8.2%
$16 to $30	27 34.2%	23 29.1%	50 31.6%
$31 to $50	33 41.8%	33 41.8%	66 41.8%
More than $50	15 19%	14 17.7%	29 18.4%
Quit Duration (Count of Participants)
Less than a week	13 16.5%	19 24.1%	32 20.3%
1 week to 1 month	18 22.8%	17 21.5%	35 22.2%
1 month to 6 months	23 29.1%	22 27.8%	45 28.5%
6 months to 1 year	15 19%	13 16.5%	28 17.7%
More than 1 year	7 8.9%	6 7.6%	13 8.2%
N/A	3 3.8%	2 2.5%	5 3.2%
Prior Quit Attempts (Count of Participants)
0	5 6.3%	5 6.3%	10 6.3%
1	12 15.2%	19 24.1%	31 19.6%
2	16 20.3%	20 25.3%	36 22.8%
3	17 21.5%	11 13.9%	28 17.7%
4	6 7.6%	12 15.2%	18 11.4%
5	12 15.2%	4 5.1%	16 10.1%
N/A	11 13.9%	8 10.1%	19 12%

Outcome Measures

1. Primary Outcome

Title	30-Day Sustained Abstinence From Smoking
Description	Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
Time Frame	Upon completion of 8-week period

Outcome Measure Data

Analysis Population Description

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/Group Title	Treatment A Mobile Application (CT-101-M)	Treatment B Mobile Application (QuitGuide)
Arm/Group Description	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 Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application
Measure Participants	79	79
Reported Smoking in the Last 30 Days	69 87.3%	66 83.5%
Reported Not Smoking in the Last 30 Days	10 12.7%	13 16.5%

2. Secondary Outcome

Title	Feasibility of Biochemical Verification of Smoking Cessation
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment A Mobile Application (CT-101-M)	Treatment B Mobile Application (QuitGuide)
Arm/Group Description	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 Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application
Measure Participants	47	46
Mean (Standard Deviation) [PPM]	9.766 (11.099)	8.609 (9.448)

3. Secondary Outcome

Title	NRT and Smoking Cessation Pharmacotherapy Use
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment A Mobile Application (CT-101-M)	Treatment B Mobile Application (QuitGuide)
Arm/Group Description	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 Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application
Measure Participants	79	79
Used NRT (or other pharmaceutical quit aids)	10 12.7%	15 19%
Did not Use NRT (or other pharmaceutical quit aids)	56 70.9%	41 51.9%
Not Reported	13 16.5%	23 29.1%

Adverse Events

Time Frame	AE collection occurred 8 weeks after participant began treatment.
Adverse Event Reporting Description	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.
Arm/Group Title	Treatment A Mobile Application (CT-101-M)		Treatment B Mobile Application (QuitGuide)
Arm/Group Description	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 Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application
All Cause Mortality
	Treatment A Mobile Application (CT-101-M)		Treatment B Mobile Application (QuitGuide)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		0/79 (0%)
Serious Adverse Events
	Treatment A Mobile Application (CT-101-M)		Treatment B Mobile Application (QuitGuide)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/79 (0%)		1/79 (1.3%)
Endocrine disorders
Diabetic Ketoacidosis	0/79 (0%)	0	1/79 (1.3%)	1
Other (Not Including Serious) Adverse Events
	Treatment A Mobile Application (CT-101-M)		Treatment B Mobile Application (QuitGuide)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/79 (13.9%)		5/79 (6.3%)
Gastrointestinal disorders
Acute Gastroenteritis	1/79 (1.3%)	1	0/79 (0%)	0
General disorders
Concussion with no loss of consciousness	1/79 (1.3%)	1	0/79 (0%)	0
Infections and infestations
Influenza	0/79 (0%)	0	1/79 (1.3%)	1
Musculoskeletal and connective tissue disorders
Fractured Coccyx	1/79 (1.3%)	1	0/79 (0%)	0
Knee Osteoarthritis	0/79 (0%)	0	1/79 (1.3%)	1
Pregnancy, puerperium and perinatal conditions
Miscarriage	1/79 (1.3%)	1	0/79 (0%)	0
Psychiatric disorders
Borderline Personality	1/79 (1.3%)	1	0/79 (0%)	0
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection Viral NOS	3/79 (3.8%)	3	1/79 (1.3%)	1
Acute Bronchitis	1/79 (1.3%)	1	0/79 (0%)	0
Acute Upper Respiratory Tract Infection	2/79 (2.5%)	2	2/79 (2.5%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.