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Examining the Efficacy of a Newly Developed Smoking Cessation Program

NCT ID: NCT06746025

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-28

Study Completion Date

2024-12-21

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Nicotine Addiction Smoking Cessation

Keywords

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smoking quit smoking addiction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Session 1

Approximately 15-20 participants that have selected Session 1 as their preferred session

Quit Center cessation program

Intervention Type BEHAVIORAL

Lifestyle modifications based on the Quit Center cessation program.

Interventions

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Quit Center cessation program

Lifestyle modifications based on the Quit Center cessation program.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quit Center LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Richard Rubino

Role: STUDY_DIRECTOR

Quit Center LLC, Managing Member

Locations

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QuitCenter.org

Beaufort, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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052024CESS

Identifier Type: -

Identifier Source: org_study_id