Clinical trial NCT06746025: Examining the Efficacy of a Newly Developed Smoking Cessation Program
Official title: Study of Newly Developed Program Designed to Create Greater Long-term Smoking Cessation Results.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nicotine Addiction
Smoking Cessation
Keywords: smoking
quit smoking
addiction
Lead sponsor: Quit Center LLC
Sponsor class: INDUSTRY
First posted: 2024-12-24
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study, although offered without geographical limitations, will be linited to United States residents

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Initial Cessation
timeFrame: 8 weeks
Secondary outcomes:
measure: Extended Cessation
timeFrame: 6 months
measure: Permanent Cessation
timeFrame: 1 year
Other outcomes:
Locations:
city: Beaufort
country: United States
facility: QuitCenter.org
state: North Carolina
Study officials:
affiliation: Quit Center LLC, Managing Member
name: Richard Rubino
role: STUDY_DIRECTOR
References: