Nicotine Addiction, Smoking Cessation
Conditions
Keywords
smoking, quit smoking, addiction
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALQuit Center cessation program
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.
Sponsors
Quit Center LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 3. currently using nicotine replacement therapy of any kind
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence at End of Program | 8 Weeks | Percentage of participants who self-report abstinence from smoking and/or vaping at the end of the 8-week program. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Tobacco Abstinence at 4-6 Months Post-program | 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. |
Countries
United States
Contacts
STUDY_DIRECTORRichard Rubino
Quit Center LLC, Managing Member
Participant flow
Recruitment details
Approximately 2,500 individuals expressed interest in participating in the study. Of these, approximately 2,000 were excluded based on failure to meet inclusion criteria or the presence of one or more exclusion criteria. The remaining eligible individuals were considered for enrollment, of whom 371 were enrolled in the program.
Pre-assignment details
Participants were enrolled in a structured 8-week smoking cessation program. Details regarding participant progression and completion are provided in the Participant Flow section.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 341 Participants |
| Sex: Female, Male Female | 147 Participants |
| Sex: Female, Male Male | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed