NCT Number: NCT06088498
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Tampa, Florida, 33612, United States
Location status: Recruiting
Christine Vinci, PhD
PRINCIPAL_INVESTIGATOR
Damon Vadrine, DRPH
SUB_INVESTIGATOR
Kara Wiseman, PhD, MPH
SUB_INVESTIGATOR
Karen Brandon
CONTACT
Katrina Vickerman, PhD
SUB_INVESTIGATOR
Kea Turner, PhD
SUB_INVESTIGATOR
Lee Ritterbrand, PhD
SUB_INVESTIGATOR
Margaret Byrne, PhD
SUB_INVESTIGATOR
Marilyn Horta, PhD
CONTACT
Steve Sutton, PhD
SUB_INVESTIGATOR
Thomas Brandon, PhD
SUB_INVESTIGATOR
The aims of the study are: (1) to update a recently developed study-related smartphone application to reduce cravings to smoke to be an engaging, user-friendly treatment tool, and verify user satisfaction; and (2) to test in a randomized controlled trial the efficacy of the app as an adjunct to quitline smoking cessation treatment in improving smoking abstinence compared to the quitline only.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 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.
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.
Time frame: At 1 Week
Participants' perception of usability and learnability of the app will be measured using 10 items on a 5-point Likert scale. Scores range from 0 to 100, with higher scores indicating better usability.
Time frame: At 6 Months
Self-report of no combustible tobacco use in the past 7 days
Time frame: At 1 Week
One Likert scale item will capture participants' satisfaction with the app. The Likert scale is from 1 to 4, with higher score indicating greater satisfaction.
Contact information is provided by the study sponsor or research team.
H. Lee Moffitt Cancer Center and Research Institute
Other
Augmented Reality as an Adjunct to Quitline Counseling for Smoking Cessation
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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