The Positively Quit Trial for Smoking Cessation

This study is testing two programs, "Positively Me" and "Positively Living," to help people quit smoking. Both programs are designed for individuals with certain health conditions and involve 12 group sessions delivered online. The main goal is to see if "Positively Me," which focuses on quitting smoking, works better than "Positively Living," which is a general healthy living program, at helping people stop smoking. All participants will receive advice to quit and an offer of nicotine replacement therapy (NRT) patches. To join, you must be at least 18 years old, smoke cigarettes, test positive for cotinine (a marker of nicotine use), be motivated to quit, and have a smartphone, laptop, or tablet with internet access for online group sessions. The study will measure if you successfully quit smoking after one year.

Study design
This is an interventional study comparing two behavioral programs. It plans to enroll 482 participants.
What's involved
You would participate in 12 online group sessions. Your smoking status will be checked at 360 days.
Compensation
Not stated in the trial record.
Follow-up
Your smoking status will be checked at 360 days after starting the study.

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NCT04449458

The Positively Quit Trial for Smoking Cessation

UNKNOWN
NAAges 18+InterventionalTreatment
University of South Florida
~482 participants
Updated 2024-07-23 on ClinicalTrials.gov
What's tested:Positively MePositively Living

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360
Measured over study day 360
+2 more outcomes measured
Cigarette Smoking
1 sites across 1 states
Florida1
  • Stephanie L Marhefka, PhD · PRINCIPAL_INVESTIGATOR · University of South Florida

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Eligibility criteria

Inclusion

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

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
  • Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360study day 360

    Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  • Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 360study day 360

    Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

  • Biochemically confirmed sustained abstinence (BC.SA) day 360Study day 360

    At day 42 (2 weeks post-quit day; provides a grace period), participant is asked the BC7ppa question (see outcome 1). Then, at each full and brief assessment going forward, beginning at day 90, participant is asked if she has smoked a cigarette, even a puff, since the last assessment. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC.SA will be coded as abstinence-indicating if she answers "no" to the sustained abstinence question at each assessment and cotinine levels at each assessment suggest abstinence.