NCT06746025

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 18, 2024

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
Last Updated

December 24, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

December 18, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

smokingquit smokingaddiction

Outcome Measures

Primary Outcomes (1)

  • Initial Cessation

    percentage of participants that report quitting smoking by the end of the program

    8 weeks

Secondary Outcomes (2)

  • Extended Cessation

    6 months

  • Permanent Cessation

    1 year

Study Arms (1)

Session 1

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

Behavioral: Quit Center cessation program

Interventions

Lifestyle modifications based on the Quit Center cessation program.

Session 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study, although offered without geographical limitations, will be linited to United States residents

You may qualify if:

  • 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

You may not qualify if:

  • currently enrolled in any weight-loss program
  • currently enrolled in any behavioral modification program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

QuitCenter.org

Beaufort, North Carolina, 28516, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderSmoking CessationSmokingBehavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehaviorCompulsive BehaviorImpulsive Behavior

Study Officials

  • Richard Rubino

    Quit Center LLC, Managing Member

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2024

First Posted

December 24, 2024

Study Start

October 28, 2024

Primary Completion

December 15, 2024

Study Completion

December 21, 2024

Last Updated

December 24, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

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.

Locations