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Innovative Digital Therapeutic for Smoking Cessation
NA trial testing CT-101-M in Smoking Cessation in 158 participants. Completed in 14 March 2019.
| Lead sponsor | My Digital Study |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 158 |
| Start date | 24 October 2018 |
| Primary completion | 14 March 2019 |
| Estimated completion | 14 March 2019 |
| Sites | 1 location across United States |
My Digital Study
Adults 18 to 65, any sex, with Smoking Cessation or Nicotine Addiction. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Self-reported abstinence from smoking was assessed in the 8-Week Outcome Survey.
| Group | Value | 95% CI |
|---|---|---|
| Treatment A Mobile Application (CT-101-M) | 69 | |
| Treatment B Mobile Application (QuitGuide) | 66 | |
| Treatment A Mobile Application (CT-101-M) | 10 | |
| Treatment B Mobile Application (QuitGuide) | 13 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment A Mobile Application (CT-101-M) | 9.766 | ± 11.099 |
| Treatment B Mobile Application (QuitGuide) | 8.609 | ± 9.448 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Treatment A Mobile Application (CT-101-M) | 10 | |
| Treatment B Mobile Application (QuitGuide) | 15 | |
| Treatment A Mobile Application (CT-101-M) | 56 | |
| Treatment B Mobile Application (QuitGuide) | 41 | |
| Treatment A Mobile Application (CT-101-M) | 13 | |
| Treatment B Mobile Application (QuitGuide) | 23 |
Time frame: AE collection occurred 8 weeks after participant began treatment.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment A Mobile Applica… | Treatment B Mobile Applica… |
|---|---|---|---|
| Diabetic Ketoacidosis | Endocrine disorders | — | — |
| Reaction | System | Treatment A Mobile Applica… | Treatment B Mobile Applica… |
|---|---|---|---|
| Upper Respiratory Tract Infection Viral NOS | Respiratory, thoracic and mediastinal disorders | — | — |
| Acute Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Miscarriage | Pregnancy, puerperium and perinatal conditions | — | — |
| Concussion with no loss of consciousness | General disorders | — | — |
| Fractured Coccyx | Musculoskeletal and connective tissue disorders | — | — |
| Borderline Personality | Psychiatric disorders | — | — |
| Acute Gastroenteritis | Gastrointestinal disorders | — | — |
| Acute Bronchitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Knee Osteoarthritis | Musculoskeletal and connective tissue disorders | — | — |
| Influenza | Infections and infestations | — | — |
Most-reported serious reactions: Diabetic Ketoacidosis.
Data from ClinicalTrials.gov NCT03694327 adverse events section.
This study is comparing the efficacy of two smoking cessation apps.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing