Nicotine AddictionESCaPeNCT06746025
Evaluation of a Smoking Cessation Program for Long-Term Abstinence
An observational study of Nicotine Addiction and Smoking Cessation, run by Quit Center LLC at 1 site in United States.
Trial summary
This observational study evaluates a structured smoking cessation program delivered via weekly group sessions. The primary objective is to assess participant-reported smoking abstinence following completion of the program and at 6-month follow-up. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nicotine Addiction, Smoking Cessation
- What is being tested?
- Quit Center cessation program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 371 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to 25 Jul 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study, although offered without geographical limitations, will be limited to United States residents
Who may be able to join
- must be addicted to nicotine either by cigarette or vaping
- must have access to an internet connected device, laptop, or smartphone
- must be 18 years old or older
Who cannot join
- currently enrolled in any weight-loss program
- currently enrolled in any behavioral modification program
- currently using nicotine replacement therapy of any kind
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study Evaluating a Smoking Cessation Program and Its Association With Long-Term Smoking Abstinence
This observational study evaluates a structured smoking cessation program delivered via weekly group sessions. The primary objective is to assess participant-reported smoking abstinence following completion of the program and at 6-month follow-up.
Secondary objectives include evaluating changes in self-reported anxiety related to smoking cessation and assessing whether participants report reduced need for ongoing trigger management. The study will also characterize the demographic profile of participants enrolled in the program.
Read more
Participants will attend weekly 1-hour group sessions conducted via videoconference over an 8-week period. Data collection includes a baseline demographic questionnaire, an end-of-program questionnaire, and a 6-month follow-up questionnaire assessing continued smoking status and related measures.
All study activities are conducted remotely, and participants may be located anywhere within the United States.
Read the detailed description
This observational study evaluates a structured, group-based smoking cessation program delivered remotely to adult participants residing in the United States. The program is conducted via weekly videoconference sessions and may be offered in both English and Spanish to accommodate participant language needs.
Eligible participants include individuals who currently use combustible cigarettes and/or electronic nicotine delivery systems (vaping products) and who are interested in attempting smoking cessation. Participants will be enrolled in an 8-week program consisting of weekly 1-hour group sessions, with approximately 15-20 participants per group.
The program is behavioral and educational in nature and does not include pharmacologic interventions or nicotine replacement therapies. Sessions are designed to provide participants with strategies intended to support smoking cessation through behavioral change, peer support, and self-directed techniques. The group-based format is intended to provide a supportive environment that may facilitate engagement and adherence to the program.
Data collection includes baseline demographic information, end-of-program assessment, and a 4-to-6 month follow-up evaluation. Outcome measures focus on participant-reported smoking status, as well as self-reported changes in anxiety related to smoking cessation and perceived need for ongoing trigger management.
The study does not evaluate the health benefits of smoking cessation, which are well established in the existing literature. Rather, the focus of this study is to assess participant outcomes associated with participation in the program and to describe the characteristics of individuals who engage in this intervention.
- Conditions
- Nicotine Addiction, Smoking Cessation
- Being tested
- Quit Center cessation program
- Keywords
- smoking, quit smoking, addiction
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Smoking, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quit Center cessation programBehavioural
A structured, group-based smoking cessation program delivered remotely through weekly 1-hour videoconference sessions over 8 weeks. The program is behavioral and educational in nature and is intended to support smoking cessation through behavioral change strategies, peer support, and self-directed techniques. The program does not include pharmacologic interventions or nicotine replacement therapies.
| Study group | Role | What they receive |
|---|---|---|
| Smoking Cessation Program Participants | Participants enrolled in a structured, group-based smoking cessation program delivered via weekly 1-hour videoconference sessions over an 8-week period. The program is behavioral and educational in nature and does not include pharmacologic interventions or nicotine replacement therapies. Receives: Behavioral: Quit Center cessation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Abstinence at End of Program
Percentage of participants who self-report abstinence from smoking and/or vaping at the end of the 8-week program.
Measured: 8 Weeks
Secondary outcomes (1)
Self-reported Tobacco Abstinence at 4-6 Months Post-program
Participants who self-reported abstinence from tobacco use at follow-up conducted between 4 and 6 months after completion of the 8-week program.
Measured: 4-6 months post-program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start28 Oct 2024
- Primary completion25 Jan 2026
- Study completion25 Jul 2026
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quit Center LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Richard Rubino, Study director, Quit Center LLC, Managing Member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746025
- Sponsor's protocol ID
- 052024CESS
- Acronym
- ESCaPe
- Status last verified
- Aug 2026
- First submitted
- 18 Dec 2024
- Last updated
- 17 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be distributed. Aggregate data will be reported and will be available for other program's usage upon request to Quit Center LLC. Quit Center LLC reserves the right to limit the distribution of aggregate data.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study Evaluating a Smoking Cessation Program and Its Association With Long-Term Smoking Abstinence
- ClinicalTrials.gov ID
- NCT06746025
- Acronym / sponsor ID
- ESCaPe / 052024CESS
- Conditions
- Nicotine Addiction, Smoking Cessation
- Keywords
- smoking, quit smoking, addiction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- Quit Center LLCIndustry (pharma, biotech, devices)
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- 25 Jan 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 24 Dec 2024 (actual)
- Results
- Posted 8 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study evaluates a structured smoking cessation program delivered via weekly group sessions. The primary objective is to assess participant-reported smoking abstinence following completion of the program and at 6-month follow-up.
Secondary objectives include evaluating changes in self-reported anxiety related to smoking cessation and assessing whether participants report reduced need for ongoing trigger management. The study will also characterize the demographic profile of participants enrolled in the program.
Participants will attend weekly 1-hour group sessions conducted via videoconference over an 8-week period. Data collection includes a baseline demographic questionnaire, an end-of-program questionnaire, and a 6-month follow-up questionnaire assessing continued smoking status and related measures.
All study activities are conducted remotely, and participants may be located anywhere within the United States.
Detailed description
This observational study evaluates a structured, group-based smoking cessation program delivered remotely to adult participants residing in the United States. The program is conducted via weekly videoconference sessions and may be offered in both English and Spanish to accommodate participant language needs.
Eligible participants include individuals who currently use combustible cigarettes and/or electronic nicotine delivery systems (vaping products) and who are interested in attempting smoking cessation. Participants will be enrolled in an 8-week program consisting of weekly 1-hour group sessions, with approximately 15-20 participants per group.
The program is behavioral and educational in nature and does not include pharmacologic interventions or nicotine replacement therapies. Sessions are designed to provide participants with strategies intended to support smoking cessation through behavioral change, peer support, and self-directed techniques. The group-based format is intended to provide a supportive environment that may facilitate engagement and adherence to the program.
Data collection includes baseline demographic information, end-of-program assessment, and a 4-to-6 month follow-up evaluation. Outcome measures focus on participant-reported smoking status, as well as self-reported changes in anxiety related to smoking cessation and perceived need for ongoing trigger management.
The study does not evaluate the health benefits of smoking cessation, which are well established in the existing literature. Rather, the focus of this study is to assess participant outcomes associated with participation in the program and to describe the characteristics of individuals who engage in this intervention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Cessation Program Participants | – | Behavioral: Quit Center cessation programParticipants enrolled in a structured, group-based smoking cessation program delivered via weekly 1-hour videoconference sessions over an 8-week period. The program is behavioral and educational in nature and does not include pharmacologic interventions or nicotine replacement therapies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study, although offered without geographical limitations, will be limited to United States residents
Key inclusion criteria (3 listed)
- must be addicted to nicotine either by cigarette or vaping
- must have access to an internet connected device, laptop, or smartphone
- must be 18 years old or older
Key exclusion criteria (3 listed)
- currently enrolled in any weight-loss program
- currently enrolled in any behavioral modification program
- currently using nicotine replacement therapy of any kind
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 |
|---|---|---|
| Quit Center cessation programA structured, group-based smoking cessation program delivered remotely through weekly 1-hour videoconference sessions over 8 weeks. The program is behavioral and educational in nature and is intended to support smoking cessation through behavioral change strategies, peer support, and self-directed techniques. The program does not include pharmacologic interventions or nicotine replacement therapies. | Behavioural | Smoking Cessation Program Participants |
Primary outcome
Smoking Abstinence at End of Program
Time frame: 8 Weeks
Percentage of participants who self-report abstinence from smoking and/or vaping at the end of the 8-week program.
1 secondary outcome
Self-reported Tobacco Abstinence at 4-6 Months Post-program
Time frame: 4-6 months post-program completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Individual participant data will not be distributed. Aggregate data will be reported and will be available for other program's usage upon request to Quit Center LLC. Quit Center LLC reserves the right to limit the distribution of aggregate data.
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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.
Richard Rubino study director
Quit Center LLC, Managing Member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nicotine Addiction and Smoking Cessation, run by Quit Center LLC 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 3 inclusion and 3 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 17 Sep 2026. 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 8 Jul 2026). 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?
Smoking Abstinence at End of Program (time frame: 8 Weeks). 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 17 Sep 2026.