Smoking CessationNCT03694327

Innovative Digital Therapeutic for Smoking Cessation

A study testing CT-101-M and QuitGuide in people with Smoking Cessation and Nicotine Addiction, run by My Digital Study at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is comparing the efficacy of two smoking cessation apps. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Smoking Cessation, Nicotine Addiction, Drug Addiction
What is being tested?: CT-101-M and QuitGuide
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 1 siteUnited States
Study dates: 24 Oct 2018to 14 Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 11Show fewer

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

Who cannot join

Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention
Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Trial locations and contacts

1 site in 1 country.

United States1 site

My Digital Study
New York, New York, 10013

Other trials in United States

About this study

Official title: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification

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

Read the 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.

Conditions: Smoking Cessation, Nicotine Addiction, Drug Addiction, Drug Dependence, Tobacco Dependence, Tobacco Use Disorder
Being tested: CT-101-M, QuitGuide
Medical subject headings: Smoking Cessation, Tobacco Use Disorder, Substance-Related Disorders, Tobacco Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT-101-MDevice
Mobile Application
QuitGuideDevice
Mobile Application

Study groups in NCT03694327
Study group	Role	What they receive
Treatment A Mobile Application	Experimental	Treatment A Digital Intervention: Smartphone application designed to assist with smoking cessation. Receives: Device: CT-101-M
Treatment B Mobile Application	Active comparator	Treatment B Digital Intervention: Smartphone application designed to assist with smoking cessation. Receives: Device: QuitGuide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

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.
Measured: Upon completion of 8-week period
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.
Measured: Upon completion of 8-week period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201814 Mar 2019

First posted3 Oct 2018
Study start24 Oct 2018
Primary completion14 Mar 2019
Study completion14 Mar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Smoking CessationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03694327
Sponsor's protocol ID: CT-101-002
Status last verified: May 2022
First submitted: 12 Sep 2018
Last updated: 6 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking Cessation trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
ClinicalTrials.gov ID: NCT03694327
Acronym / sponsor ID: CT-101-002
Conditions: Smoking Cessation, Nicotine Addiction, Drug Addiction, Drug Dependence, Tobacco Dependence, Tobacco Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: My Digital StudyIndustry (pharma, biotech, devices)
Study start: 24 Oct 2018 (actual)
Primary completion: 14 Mar 2019 (actual)
Study completion: 14 Mar 2019 (actual)
First posted: 3 Oct 2018 (actual)
Results: Posted 6 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Treatment A Mobile Application	Experimental	Device: CT-101-MTreatment A Digital Intervention: Smartphone application designed to assist with smoking cessation.
Treatment B Mobile Application	Active comparator	Device: QuitGuideTreatment B Digital Intervention: Smartphone application designed to assist with smoking cessation.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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

Key exclusion criteria (2 listed)

Prior use of Treatment A Digital Intervention or Treatment B Digital Intervention
Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT-101-MMobile Application	Device	Treatment A Mobile Application
QuitGuideMobile Application	Device	Treatment B Mobile Application

Primary outcome

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

2 secondary outcomes

Feasibility of Biochemical Verification of Smoking Cessation
Time frame: Upon completion of 8-week period
NRT and Smoking Cessation Pharmacotherapy Use
Time frame: Upon completion of 8-week period

Results and safety

Results posted to the registry on 6 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment A Mobile Application	79	66
Treatment B Mobile Application	79	56

Primary outcome: 30-Day Sustained Abstinence From Smoking

Time frame: Upon completion of 8-week period. Count of participants. Unit: Participants

Measure	Treatment A Mobile Application (CT-101-M) n = 79	Treatment B Mobile Application (QuitGuide) n = 79
Reported Smoking in the Last 30 Days	69	66
Reported Not Smoking in the Last 30 Days	10	13

Population analysed: 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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE collection occurred 8 weeks after participant began treatment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A Mobile Application (CT-101-M)	0 of 79 (0%)	11 of 79 (13.9%)	0 of 79
Treatment B Mobile Application (QuitGuide)	1 of 79 (1.3%)	5 of 79 (6.3%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Smoking Cessation

Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian M Iacoviello, PhD principal investigator

My Digital Study

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CT-101-M and QuitGuide in people with Smoking Cessation and Nicotine Addiction, run by My Digital Study at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

30-Day Sustained Abstinence From Smoking (time frame: Upon completion of 8-week period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694327.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2022.