NCT06811038

iCanQuit Smoking Cessation Among Hispanic Adults

Providing Nicotine Replacement Therapy to Enhance the Efficacy of a Smoking Cessation Smartphone App for Hispanic Adults

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 854 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.

Detailed description

OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. ARM II: Participants receive access to the iCanQuit smartphone application for 12 months and complete personalized quit plans with education regarding managing urges, motivation, and relapse prevention, on-demand help with tracking of daily cigarette consumption, and monitoring of urges passed without smoking. Participants also receive NRT patch(es) and gum or lozenges to use per the usage instructions tailored to the participants' baseline smoking levels. In addition, participants receive daily push notifications with NRT dosage and refill reminders for 12 months. After completion of study intervention, patients may be followed up at 12 months.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
DEVICE	iCanQuit Smartphone App Smoking Cessation Program	Receive access to iCanQuit app, with daily push notifications
DRUG	Nicotine Gum	Receive nicotine replacement therapy gum
DRUG	Nicotine Patch	Receive nicotine replacement therapy patch(es)
DRUG	Nicotine Lozenge	Receive nicotine replacement therapy lozenge(s)
OTHER	Survey Administration	Ancillary studies
OTHER	Interview	Ancillary studies

Timeline

• Start date: 2026-05-01
• Primary completion: 2029-07-01
• Completion: 2030-07-01
• First posted: 2025-02-06
• Last updated: 2026-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study