- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06746025
Evaluation of a Smoking Cessation Program for Long-Term Abstinence (ESCaPe)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Naples, Florida, United States, 34104
- QuitCenter.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- currently enrolled in any weight-loss program
- currently enrolled in any behavioral modification program
- currently using nicotine replacement therapy of any kind
Study Plan
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
Sponsor
Investigators
- Study Director: Richard Rubino, Quit Center LLC, Managing Member
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 052024CESS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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