Health TrialsbyHealthPanel

App for Reducing Cravings to Smoke

ConditionSmoking
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

>18 years of age

Daily smokers that have quit smoking within the past 3 months (Aim 1) or currently smoking ≥ 3 cigarettes per day for the past year (Aim 2)

Functioning telephone number

Owns a smart phone capable of supporting AR and willing to download the app

Disqualifiers

Has another household member already enrolled in the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

3,600 Participants
are divided into 3 treatment groups
Group A: Aim 1: Update an existing smartphone AppExperimental treatment 1 intervention
Group B: Aim 2: Quit Line OnlyExperimental treatment 1 intervention
Group C: Aim 2:Quitline plus smartphone AppExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

System Usability Scale (Aim 1)

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 1 Week
2

Tobacco Abstinence (Aim 2)

Self-report of no combustible tobacco use in the past 7 days

Time frame
At 6 Months

Secondary outcomes

1

User Satisfaction (Aim 1)

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.

Time frame
At 1 Week

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

H. Lee Moffitt Cancer Center and Research Institute

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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