Nicotine Replacement Therapy

iCanQuit App + Nicotine Therapy for Smoking Cessation

Seattle, WA

Phase 3

Waitlist Available

Led By Jonathan Bricker, PhD

Research Sponsored by Fred Hutchinson Cancer Center

Eligibility Criteria Checklist

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

Must have

Age 18 and older

No previous use of iCanQuit

Must not have

NRT CONTRAINDICATION: Heart attack in the last 2 months

NRT CONTRAINDICATION: Uncontrolled hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 months post randomization

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a smartphone app and nicotine replacement therapy to help Hispanic adults quit smoking. The app helps users manage cravings, stay motivated, and prevent relapse with personalized plans. Nicotine replacement therapy

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Who is the study for?

This trial is for Hispanic adults who want to quit smoking and are willing to use a smartphone app designed to help with quitting. Participants must be comfortable using the iCanQuit app, which includes managing urges and creating personalized quit plans. There's no mention of specific exclusions in the provided information.Check my eligibility

What is being tested?

The study is testing if the iCanQuit smartphone app helps people stop smoking when used alone or combined with nicotine replacement therapies like gum, patches, or lozenges. The goal is to see if these methods can ease cravings and withdrawal symptoms more effectively than just the app.See study design

What are the potential side effects?

Possible side effects may include irritation from nicotine patches or gum, oral issues from lozenges, and typical withdrawal symptoms such as headaches, mood swings, or increased appetite when quitting smoking.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have never used iCanQuit.

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Exclusion Criteria

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

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I have not had a heart attack in the last 2 months.

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My blood pressure is not well-controlled.

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I am currently taking warfarin.

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I have not had a stroke in the past 6 months.

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I have been diagnosed with an irregular or fast heartbeat.

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I am not pregnant, breastfeeding, nor planning to become pregnant in the next 6 months.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12 months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12 months post randomization

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

Treatment Details

Study Objectives

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

Primary study objectives

30-day point prevalence abstinence (PPA)

Secondary study objectives

Cost per life year gained

Cost per quality-adjusted life year (QALY) gained

Cost per quitter

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (iCanQuit application and NRT)Experimental Treatment6 Interventions

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 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.

Group II: Arm I (iCanQuit application)Experimental Treatment3 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nicotine Gum

2017

Completed Phase 4

~1350

Nicotine Patch

2011

Completed Phase 4