App for Reducing Cravings to Smoke

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06088498
Phase
PHASE2
Status
Recruiting
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Conditions

  • Smoking

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Updating Existing Smartphone App — BEHAVIORAL
    Participants will be asked to use a recently developed study smartphone application to reduce cravings to smoke for a 5-week period. Through the app, participants will be exposed to smoking extinction trials daily. Participants will be encouraged and reminded to complete 2-5 extinction sessions per day. Each session will present 3-8 cues, and each cue will be presented for 20-40 seconds (average amount of extinction per day will be about 10 minutes). Participants will be encouraged to conduct the extinction sessions when high cravings are expected.
  • Quitline Services — BEHAVIORAL
    Quitline coaches use cognitive behavioral therapy, reinforcement, and principles of self-efficacy to promote effective behavior change. The quitline approach includes 5 key elements: setting a quit date, coping with triggers, effectively using medications, tobacco proofing, and social support. Individuals who enroll in the quitline's multi-call program receive phone calls and NRT.
  • Quitline Services and Smartphone App — BEHAVIORAL
    In addition to quitline services, participants will download a study app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, those in the intervention group will be exposed to smoking extinction trials through the study smartphone app.

Study Details

The overall goal of the study is to assess the efficacy of using cue exposure delivered via a smartphone application as an adjunct to Tobacco Quitline treatment to improve smoking abstinence.

Key Dates

Start date
Jun 11, 2024
Status verified
Feb 2026
Primary completion
May 1, 2027
Completion
May 1, 2027

Study Design

Enrollment
3,600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Aim 1: Update an existing smartphone App
    An existing study app will be updated to be engaging, user-friendly treatment tool, and verify user satisfaction.
  • Experimental: Aim 2: Quit Line Only
    Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence.
  • Experimental: Aim 2:Quitline plus smartphone App
    Participants randomized to this arm will receive usual care for smoking cessation via the quitline and a smartphone app that will allow them to track smoking urges and abstinence. After 48 hours of self-reported abstinence, they will be exposed to smoking extinction trials through the study smartphone app.

Primary Outcome Measure

System Usability Scale (Aim 1) [ Time Frame: At 1 Week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Karen Brandon
[email protected]
813-745-7691
Marilyn Horta, PhD
Christine Vinci, PhD (PRINCIPAL_INVESTIGATOR)
Thomas Brandon, PhD (SUB_INVESTIGATOR)
Margaret Byrne, PhD (SUB_INVESTIGATOR)
Kea Turner, PhD (SUB_INVESTIGATOR)
Damon Vadrine, DRPH (SUB_INVESTIGATOR)
Lee Ritterbrand, PhD (SUB_INVESTIGATOR)
Kara Wiseman, PhD, MPH (SUB_INVESTIGATOR)
Katrina Vickerman, PhD (SUB_INVESTIGATOR)
Steve Sutton, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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