Recruiting

iCanQuit, Motiv8, Quit Line

Sponsor:

University of Florida

Code:

NCT05415761

Conditions

Tobacco Use Cessation

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

iCanQuit

iCanQuit+Motiv8

Florida quit line

Study Details

Brief summary:

This study will evaluate the comparative effectiveness of three smoking cessation therapies: mobile health (mHealth) application iCanQuit, mHealth application iCanQuit + Motiv8, and the Florida quit line.

Conditions

Tobacco Use Cessation

Study ID

NCT05415761

Start date

May 15, 2023

Status verified date

Nov, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • ≥21 years old
  • Referred by the provider via Ask-Advise-Connect
  • Receiving care at one of the participating clinics
  • Daily access to their own smart phone (the study team will provide assistance to patients without a phone to obtain one through aid programs for low-income patients)
  • No household members already enrolled

Exclusion Criteria:

  • Unstable medical or psychiatric illness

Study Design

Enrollment

1332 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: iCanQuit

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.

active comparator: iCanQuit+Motiv8

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.

active comparator: Florida quit line

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.

Interventions

iCanQuit

iCanQuit is a smoking cessation smart phone application that uses acceptance and commitment therapy (ACT) approach, a cognitive behavioral treatment

iCanQuit+Motiv8

iCanQuit + Motiv8 is a integrated version of iCanQuit (Cognitive Behavioral Therapy smoking cessation therapy application) with Motiv8 (a contingency management program that rewards decreased smoking determined by measuring CO levels of participant)

Florida quit line

An evidence-based, existing smoking cessation healthcare option recommended by the U.S. clinical practice that connects active smokers to trained quit coaches via referral by their providers.

Primary outcome measure

  • Smoking Point-Prevalence Abstinence (PPA) [ Time Frame: Month 6 ]

Central Contacts and Locations

Central contacts

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Principal Investigator:

Jesse Dallery, PhD

More Information

Sponsor

University of Florida

Last update posted

Jun 12, 2026

Last verified

Nov, 2025

Keywords

  • tobacco use intervention
  • mobile health aids

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-06-12.