Evaluation of a Smoking Cessation Program for Long-Term Abstinence (ESCaPe)

July 7, 2026 updated by: Quit Center LLC

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.

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.

Study Overview

Status

Active, not recruiting

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 Type

Observational

Enrollment (Actual)

371

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Naples, Florida, United States, 34104
        • QuitCenter.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

This study, although offered without geographical limitations, will be limited to United States residents

Description

Inclusion Criteria:

  1. must be addicted to nicotine either by cigarette or vaping
  2. must have access to an internet connected device, laptop, or smartphone
  3. must be 18 years old or older

Exclusion Criteria:

  1. currently enrolled in any weight-loss program
  2. currently enrolled in any behavioral modification program
  3. currently using nicotine replacement therapy of any kind

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Initial Cessation
Time Frame: 8 weeks
percentage of participants that report quitting smoking by the end of the program
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extended Cessation
Time Frame: 6 months
percentage of participants that report staying quit for an extended time period
6 months
Permanent Cessation
Time Frame: 1 year
percentage of participants that remain smoke free permanently
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Richard Rubino, Quit Center LLC, Managing Member

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2024

Primary Completion (Actual)

January 25, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 18, 2024

First Submitted That Met QC Criteria

December 20, 2024

First Posted (Actual)

December 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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