NCT04449458 · University of South Florida
The Positively Quit Trial for Smoking Cessation
What this study is about
The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered via videoconferencing groups works better than a control condition--a program that is not designed to help with smoking but that does have the same number of group contact hours as the other program (this program is called the Attention Matched Control condition; AMC) for helping people with certain health conditions stop smoking. People in both groups will receive brief advice to quit and an offer of nicotine replacement therapy patches (NRT), as well as 12 videoconferencing group sessions. The team will measure smoking behavior over a one-year period and compare smoking rates for the treatment condition against AMC to see if the treatment condition is better at getting people living with certain health conditions to quit smoking.
View original scientific description
The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered via videoconferencing groups works better than a control condition--a program that is not designed to help with smoking but that does have the same number of group contact hours as the other program (this program is called the Attention Matched Control condition; AMC) for helping people with certain health conditions stop smoking. People in both groups will receive brief advice to quit and an offer of nicotine replacement therapy patches (NRT), as well as 12 videoconferencing group sessions. The team will measure smoking behavior over a one-year period and compare smoking rates for the treatment condition against AMC to see if the treatment condition is better at getting people living with certain health conditions to quit smoking.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- greater than or equal to age 18 (as NRT is not FDA approved for adolescents)
- self-report smoking cigarettes
- positive cotinine test
- motivated to quit
- own a smart phone, laptop, desktop, or tablet computer
- able to join group from a private space with Internet access
- demonstrate the ability to connect to the HIPAA-compliant videoconferencing system, Zoom, over the internet h) speak English i) living in the US j) living with certain health conditions
Exclusion criteria
- pregnant, breastfeeding, or have other contraindications to NRT
- receiving other tobacco treatment, or
- inability to communicate coherently in English during the video-conferencing test or other pre-enrollment interactions
Where
- Tampa, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2024 · Source of record for eligibility and locations