Recruiting

Smoking Cessation

Sponsor:

University of South Florida

Code:

NCT04449458

Conditions

Cigarette Smoking

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Positively Me

Positively Living

Study Details

Brief summary:

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.

Conditions

Cigarette Smoking

Study ID

NCT04449458

Start date

Jun 10, 2020

Status verified date

Jul, 2024

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

482 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Positively Me

Positively Me is a 12-session (8 \[1.5\] hour main sessions plus four booster sessions) intervention guided by Social Cognitive Theory to promote smoking cessation in people with certain health conditions.

sham comparator: Positively Living

Positively Living is a modified updated version of a healthy living intervention based on Social Cognitive Theory that is designed for people with certain health conditions and attention-matched to the experimental condition (8 \[1.5\] hour main sessions plus four booster sessions).

Interventions

Positively Me

12 session smoking cessation intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)

Positively Living

12 session healthy living intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)

Primary outcome measure

  • Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360 [ Time Frame: study day 360 ]
  • Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 360 [ Time Frame: study day 360 ]
  • Biochemically confirmed sustained abstinence (BC.SA) day 360 [ Time Frame: Study day 360 ]

Central Contacts and Locations

Central contacts

Catheryn Flores, MPH

813-396-2014catherynf@usf.edu

Shanna Hunt

sphunt@usf.edu

Locations

University of South Florida, College of Nursing

Recruiting

Tampa, Florida, United States, 33612

Contacts

Catheryn Flores, MPH

813-396-2014catherynf@usf.edu

Stephanie L Marhefka, PhD

813-974-5810smarhefk@usf.edu

Principal Investigator:

STEPHANIE L Marhefka, PhD

More Information

Sponsor

University of South Florida

Last update posted

Jul 23, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2024-07-23.