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Behavioral Intervention

Mobile Health Smoking Cessation for Quitting Smoking (PROMOTE-UP Trial)

N/A

Recruiting

Led By Ramzi Salloum, PhD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥21 years old

Be older than 18 years old

Must not have

Unstable medical or psychiatric illness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 6 and 12

Awards & highlights

No Placebo-Only Group

Summary

This trial tests 3 methods to help smokers quit: a mobile app, a mobile app + support, and a quit line.

Who is the study for?

This trial is for individuals over 21 who smoke and want to quit. They must have daily access to a smartphone, be referred by their primary care provider, and receive care at a participating clinic. People with unstable medical or psychiatric conditions cannot join.

What is being tested?

The study compares three smoking cessation methods: the iCanQuit mobile app, iCanQuit combined with another app called Motiv8, and the Florida quit line service. It aims to find out which is most effective in helping underserved patients stop smoking.

What are the potential side effects?

Since this trial involves behavioral interventions like apps and counseling services rather than medications, there are no direct side effects as you would expect from drugs; however, participants may experience stress or frustration during the quitting process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 21 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any unstable medical or mental health conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 6 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Acceptance

Motivation

Quality of Life and Well-Being

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: iCanQuit+Motiv8Active Control1 Intervention

Motiv8 is an internet-and smart phone-based contingency management (CM) intervention. Motiv8 verifies smoking status via a hand-held breath carbon monoxide (CO) monitor that is connected to a smart phone. For patients randomized to the iCanQuit+Motiv8 arm (444 total), research staff will assist in downloading the combined pp and connecting the iCO to the patient's phone. Smokers will also be asked to complete the first 4 iCanQuit modules, which contain exercises designed to prepare the users for their quit day. The end of the preparation phase will also mark each patient's quit date. During the intervention (7 weeks), participants will be considered abstinent from smoking if their breath CO sample is ≤ 5 ppm or if the CO value has decreased by 5% per hour from the last sample provided.

Group II: Florida quit lineActive Control1 Intervention

The Florida quit line provides telephone counseling for smoking cessation. Patients randomized to the Florida quit line arm (444 total) will be enrolled after contact information is sent electronically.

Group III: iCanQuitActive Control1 Intervention

iCanQuit is a modern, cognitive behavioral treatment which promotes cessation through greater acceptance of triggers for smoking and commitment to personal values. It is a smart phone-based acceptance and commitment therapy (ACT). For patients randomized to the iCanQuit arm (444 total), research staff will assist in downloading the app onto the patient's phone.

0 / 2Eligibility criteria met