Examining the Efficacy of a Newly Developed Smoking Cessation Program (ESCaPe)

Study of Newly Developed Program Designed to Create Greater Long-term Smoking Cessation Results.

The goal of this clinical trial is to determine the success rate (efficacy) of a newly developed program to help smokers and vapers quit smoking. There will be no drugs of any nature involved, nor will there be any replacement addictions offered (ie; patches, gummies, etc.) It will also learn about the demographic profile of inbound participants. The main questions it aims to answer are:

Does the new program offer an improved success rate for smoking cessation? Does the program eliminate the need for long term "trigger" management? Does the program effectively diminish the anxiety that is normally associated with smoking cessation?

Participants will:

Attend a 1 hour group zoom session each week for the duration of the program (8 weeks).

Fill out an onboarding demographic questionnaire and exit demographic questionnaire.

Agree to a 6 month follow up questionnaire regarding their continued success/failure.

There are no physical meeting requirements. Participants can be located anywhere within the US.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Nicotine Addiction
• Intervention / Treatment: Behavioral: Quit Center cessation program

Detailed Description

Participants will be sourced from within the United States. At this time, even though the program will be delivered online, the trial will be limited to US residents. It is anticpated that there will be a percentage of the participants that speak English as a second language, and therefore the Sponsor will also offer several sessions in Spanish. Participants MUST currently be smokers or vapers, as the basis of the test is to determine the anticipated success rate for participants to quit smoking.

The medical and emotional benefits of quitting smoking and ending nicotine addiction have been exhaustively tested in many previous studies and trials. The results of which are indisputable. This trial will not be assessing the ultimate benefits to ending the nicotine addiction. The primary purpose of this trial is to assess the efficacy of the holistic approach to quitting, and to gauge the program results against any currently extant methods. The program will instruct participants in ways to end their addiction to cigarettes and/or vaping, using their body's own natural abilities. It does NOT purport to be a medical solution, nor will any drugs be recommended or prescribed. There will also be NO reliance on other currently available medical/non-medical replacement therapies (ie; patches, gummies, hypnotism, prescription medication, etc,) and none of the personnel conducting any segment of the trial will be authorized to discuss or recommend any medical treatments whatsoever. The ultimate goal of the program is to completely eliminate the triggers that so often derail the effort to quit smoking.

Participants will step through an 8 week program, during which they will be shown ways to make incremental lifestyle changes that result in the cessation of the smoking addiction. The process is a holistic approach using the body's natural processes to eliminate anxiety. Additionally, each session will comprise groups of between 15-20 smokers. This will provide the "community" effect that will also add to the efficacy of the percentages.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Beaufort, North Carolina, United States, 28516
      • QuitCenter.org

Participation Criteria

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 linited 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Session 1; Approximately 15-20 participants that have selected Session 1 as their preferred session	Behavioral: Quit Center cessation program; Lifestyle modifications based on the Quit Center cessation program.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2024
• Primary Completion (Actual): December 15, 2024
• Study Completion (Actual): December 21, 2024

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: addiction; smoking; quit smoking
• Additional Relevant MeSH Terms: Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Compulsive Behavior; Impulsive Behavior; Tobacco Use Disorder; Behavior, Addictive
• Other Study ID Numbers: 052024CESS

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