Nicotine AddictionNCT05440721
Clinical Trial of an Innovative Digital Therapeutic for Smoking Cessation With Biochemical Verification
A study testing Treatment A with device Clickotine® (Active intervention) in people with Nicotine Addiction and Drug Addiction, run by Click Therapeutics, Inc. at 1 site in United States.
Trial summary
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction, Drug Addiction, Drug Dependence
- What is being tested?
- Treatment A with device Clickotine® (Active intervention)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2018to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65
- Smokes at least 5 cigarettes daily
- Is interested in quitting in the next 30 days
- Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
- Willing and able to receive SMS text messages
- Able to comprehend the English-language and the informed consent form
Show all 9Show fewer
- Lives in the United States
- 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 from a Magellan Behavioral Health value-based care network
Who cannot join
- Prior use of Clickotine or QuitGuide
- Current use of pharmacotherapy for smoking cessation or nicotine replacement therapy (NRT)
Trial locations and contacts
1 site in 1 country.
About this study
This study is evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
Read the detailed description
The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.
- Conditions
- Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence
- Being tested
- Treatment A with device Clickotine® (Active intervention), Treatment B with smoking education (control)
- Keywords
- Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
- Medical subject headings
- Tobacco Use Disorder, Substance-Related Disorders, Smoking, Cigarette Smoking, Tobacco Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment A with device Clickotine® (Active intervention)Device
The intervention regimen around Treatment A is almost entirely user-directed. When a person has a craving, a series of options are available to ease the craving and resist the urge to smoke. The user will also engage with Clickotine® leading up to their quit date to complete a program of 21 Missions, daily activities which help prepare them to quit and keep them off cigarettes. Ideally, the user will open and use Treatment A several times a day.
Treatment B with smoking education (control)Device
The Treatment B app is operated by the National Cancer Institute to provide education and support to smokers seeking to quit. The QG regimen is entirely user-directed. When a user has a craving or wants support or education, they can log into the QG app. The QG app also provides lessons relevant for preparing to quit and beginning to quit.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (device Clickotine®) | Active comparator | User will open and use Treatment A (Clickotine® device) several times a day up to their quit date to complete a program of 21 Missions. Receives: Device: Treatment A with device Clickotine® (Active intervention) |
| Treatment B (smoking education) | Sham comparator | Treatment B app provides education and support to smokers seeking to quit. When a user has a craving or wants support or education, they can log into the app. Receives: Device: Treatment B with smoking education (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure:
The primary objective is to confirm the improved efficacy of CKT for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs. QuitGuide.
**Acceptance criteria: Self-reported 30 day point prevalence quit rates will be significantly higher in the CKT arm than QuitGuide.
Measured: [Time Frame: 8 week core study]
Secondary outcomes (3)
Secondary Outcome Measure
A secondary objective of the study is to establish the feasibility of biochemical verification of smoking cessation in a fully remote, digital clinical trial.
Measured: [Time Frame: 8 week core study]
Secondary Outcome Measure
A secondary objective of the study is to compare cessation rates between the CKT+NRT group and the CKT-only group, to address expected med/NRT use during the trial and to confirm the initial trial result that CKT+NRT is not superior to CKT-alone.
Measured: [Time Frame: 8 week core study]
Secondary Outcome Measure
A secondary objective of the study is to demonstrate the feasibility of evaluating CKT in a Magellan Behavioral Health (A Click Therapeutics partner) value-based care population
Measured: [Time Frame: 8 week core study]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study start25 Oct 2018
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Change of company's priority; learning from a separate CT-101-CLS-001 (NCT04857515) is deemed sufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, MDPhD, FAAN, Study chair, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440721
- Sponsor's protocol ID
- CT-101-002
- Status last verified
- Jun 2022
- First submitted
- 22 Jun 2022
- Last updated
- 1 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 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
- NCT05440721
- Acronym / sponsor ID
- CT-101-002
- Conditions
- Nicotine Addiction, Drug Addiction, Drug Dependence, Substance Use Disorder, Tobacco Dependence
- Keywords
- Smoking, Cigarette Smoking, Tobacco Smoking, Nicotine, Drug, Addiction, Tobacco
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change of company's priority; learning from a separate CT-101-CLS-001 (NCT04857515) is deemed sufficient
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Jul 2022 (actual)
- Results
- Not posted in the source record
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 evaluating the efficacy of Treatment A for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs.Treatment B.
Detailed description
The overarching study aim is to recruit a population of current smokers who are motivated to quit with the assistance of a mobile solution, enroll them into a study testing apps to help them quit, and randomize them into one of two arms. The core study period will consist of 8 weeks of usage of Treatment A or Treatment B. At the end of this period, users will receive notifications to link them to an online survey, which will record their responses in a secure database.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A (device Clickotine®) | Active comparator | Device: Treatment A with device Clickotine® (Active intervention)User will open and use Treatment A (Clickotine® device) several times a day up to their quit date to complete a program of 21 Missions. |
| Treatment B (smoking education) | Sham comparator | Device: Treatment B with smoking education (control)Treatment B app provides education and support to smokers seeking to quit. When a user has a craving or wants support or education, they can log into the app. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 65
- Smokes at least 5 cigarettes daily
- Is interested in quitting in the next 30 days
- Owns an iPhone with iOS 9 or higher or Android with OS 4.1 or higher
- Willing and able to receive SMS text messages
Key exclusion criteria (2 listed)
- Prior use of Clickotine or QuitGuide
- 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 |
|---|---|---|
| Treatment A with device Clickotine® (Active intervention)The intervention regimen around Treatment A is almost entirely user-directed. When a person has a craving, a series of options are available to ease the craving and resist the urge to smoke. The user will also engage with Clickotine® leading up to their quit date to complete a program of 21 Missions, daily activities which help prepare them to quit and keep them off cigarettes. Ideally, the user will open and use Treatment A several times a day. | Device | Treatment A (device Clickotine®) |
| Treatment B with smoking education (control)The Treatment B app is operated by the National Cancer Institute to provide education and support to smokers seeking to quit. The QG regimen is entirely user-directed. When a user has a craving or wants support or education, they can log into the QG app. The QG app also provides lessons relevant for preparing to quit and beginning to quit. | Device | Treatment B (smoking education) |
Primary outcome
Primary Outcome Measure:
Time frame: [Time Frame: 8 week core study]
The primary objective is to confirm the improved efficacy of CKT for short-term smoking cessation through a blinded randomized controlled trial (RCT) vs. QuitGuide. **Acceptance criteria: Self-reported 30 day point prevalence quit rates will be significantly higher in the CKT arm than QuitGuide.
3 secondary outcomes
Secondary Outcome Measure
Time frame: [Time Frame: 8 week core study]
Secondary Outcome Measure
Time frame: [Time Frame: 8 week core study]
Secondary Outcome Measure
Time frame: [Time Frame: 8 week core study]
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2022.
- Individual participant dataSharing planned: No
Related trials for Nicotine Addiction
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
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product
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.
Shaheen Lakhan, MDPhD, FAAN study chair
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment A with device Clickotine® (Active intervention) in people with Nicotine Addiction and Drug Addiction, run by Click Therapeutics, Inc. 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 9 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: withdrawn, as of the sponsor's last update on 1 Jul 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Outcome Measure: (time frame: [Time Frame: 8 week core study]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jul 2022.