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This study is comparing the efficacy of two smoking cessation apps.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A Mobile Application | Experimental | Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation. |
|
| Treatment B Mobile Application | Active Comparator | Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-101-M | Device | Mobile Application |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 30-Day Sustained Abstinence From Smoking | Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey. | Upon completion of 8-week period |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Upon completion of 8-week period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian M Iacoviello, PhD | My Digital Study | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| My Digital Study | New York | New York | 10013 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | Treatment B Mobile Application | Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | Treatment B Mobile Application (QuitGuide) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Measured via Self-Report in the Baseline Survey. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 30-Day Sustained Abstinence From Smoking | Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey. | 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 | Posted | Count of Participants | Participants | Upon completion of 8-week period |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic Ketoacidosis | Endocrine disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alankar Gupta, VP, Medical Affairs & Clinical Development | MyDigitalStudy | 862-485-9279 | agupta@clicktherapeutics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 10, 2022 | Mar 10, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2022 | Mar 10, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D014029 | Tobacco Use Disorder |
| D019966 | Substance-Related Disorders |
| D000073869 | Tobacco Smoking |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| QuitGuide |
| Device |
Mobile Application |
|
| 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. |
| Upon completion of 8-week period |
Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
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| Region of Enrollment | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
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| Family Size, Categorical | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
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| Education, Categorical | Measured via Self-Report in the Baseline Survey. | Number | participants |
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| Income Range, Categorical | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
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| Internet Frequency, Categorical | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
|
| Fagerstrom Test for Nicotine Dependence | The Fagerstrom Test for Nicotine Dependence is a standard instrument for assessing the intensity of physical addiction to nicotine. The test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. In scoring the Fagerstrom Nicotine Dependency Test, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are added to yield a total score of 0-10. The higher total Fagerstrom score indicates a more intense/ higher dependency to nicotine (Heatherton, et. al, 1991) | Count of Participants | Participants |
|
| Money Spent on Cigarettes (Per Month) | Measured via Self-Report in the Baseline Survey. | Count of Participants | Participants |
|
| Quit Duration | Participants longest prior quit attempt was measured via self-report in the Baseline Survey. | Count of Participants | Participants |
|
| Prior Quit Attempts | Participants prior quit attempts were measured via self-report in the Baseline Survey. | Count of Participants | Participants |
|
| OG001 | Treatment B Mobile Application (QuitGuide) | Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application |
|
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| 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. | Posted | Mean | Standard Deviation | PPM | Upon completion of 8-week period |
|
|
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| 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. | Posted | Count of Participants | Participants | Upon completion of 8-week period |
|
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| 0 |
| 79 |
| 0 |
| 79 |
| 11 |
| 79 |
| EG001 | Treatment B Mobile Application (QuitGuide) | Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. QuitGuide: Mobile Application | 0 | 79 | 1 | 79 | 5 | 79 |
| Upper Respiratory Tract Infection Viral NOS | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Concussion with no loss of consciousness | General disorders | MedDRA | Non-systematic Assessment |
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| Fractured Coccyx | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Borderline Personality | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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| Acute Gastroenteritis | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Knee Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Acute Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Non-systematic Assessment |
|
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| D012907 |
| Smoking |
| D064424 | Tobacco Use |
| Not Reported |
|