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Active, Not Recruiting

NCT Number: NCT06746025

Evaluation of a Smoking Cessation Program for Long-Term 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Nicotine Addiction Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Health Behavior Impulsive Behavior Mental Disorders Smoking Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

QuitCenter.org

Naples, Florida, 34104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quit Center cessation program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Self-reported Tobacco Abstinence at 4-6 Months Post-program

    Time frame: 4-6 months post-program completion

    Participants who self-reported abstinence from tobacco use at follow-up conducted between 4 and 6 months after completion of the 8-week program.

Sponsors and collaborators

Lead sponsor

Quit Center LLC

Industry

Registry information

Official study title

Observational Study Evaluating a Smoking Cessation Program and Its Association With Long-Term Smoking Abstinence

Acronym: ESCaPe

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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