The Positively Quit Trial for Smoking Cessation

Part of paid clinical trials in Tampa, Florida.

Sponsor
University of South Florida
Study ID
NCT04449458
Status
Recruiting
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Conditions

  • Cigarette Smoking

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Positively Me — BEHAVIORAL
    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 — BEHAVIORAL
    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)

Study Details

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.

Key Dates

Start date
Jun 10, 2020
Status verified
Jul 2024
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
482 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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).

Primary Outcome Measure

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360 [ Time Frame: study day 360 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South Florida, College of NursingTampaFlorida33612
Catheryn Flores, MPH
[email protected]
813-396-2014
Stephanie L Marhefka, PhD
[email protected]
813-974-5810
STEPHANIE L Marhefka, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of South Florida, College of Nursing· Tampa, FL

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