854 Participants Needed

iCanQuit App + Nicotine Therapy for Smoking Cessation

JB
Overseen ByJonathan Bricker, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Fred Hutchinson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using other smoking cessation interventions or if you are using warfarin.

What data supports the effectiveness of the iCanQuit App + Nicotine Therapy treatment for smoking cessation?

Research shows that nicotine replacement therapies like patches, gum, and lozenges help many people quit smoking. Combining different nicotine therapies, such as a patch with another form, may be even more effective. This suggests that using the iCanQuit App along with nicotine products could help people stop smoking.12345

Is the iCanQuit App + Nicotine Therapy safe for humans?

Nicotine replacement therapies like gum, lozenges, and patches are generally safe for most people, including those with heart conditions, but should be used cautiously during pregnancy. These therapies are well-tolerated, with minor side effects reported, and are effective in helping people quit smoking.56789

How does the iCanQuit App + Nicotine Therapy treatment differ from other smoking cessation treatments?

The iCanQuit App + Nicotine Therapy is unique because it combines digital support through an app with traditional nicotine replacement therapies like gum, lozenges, and patches, potentially enhancing motivation and support for quitting smoking. This approach integrates behavioral support with pharmacological intervention, which may improve quit rates compared to using nicotine replacement alone.1571011

What is the purpose of this trial?

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.

Research Team

JB

Jonathan Bricker, PhD

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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.

Inclusion Criteria

No household or family member participating
I am willing to attend follow-up assessments at 3, 6, and 12 months.
Self-identify as Hispanic ethnicity
See 11 more

Exclusion Criteria

I have not had a heart attack in the last 2 months.
My blood pressure is not well-controlled.
I have been diagnosed with an irregular or fast heartbeat.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive access to the iCanQuit smartphone application for 12 months, with personalized quit plans and education on managing urges, motivation, and relapse prevention. Arm II participants also receive NRT patches and gum or lozenges.

12 months

Follow-up

Participants are monitored for smoking cessation outcomes and cost-effectiveness measures at 12 months post-randomization.

12 months

Treatment Details

Interventions

  • iCanQuit Smartphone App Smoking Cessation Program
  • Nicotine Gum
  • Nicotine Lozenge
  • Nicotine Patch
Trial Overview 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.
Participant Groups
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
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials
583
Recruited
1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

Medicinal nicotine has significantly improved smoking cessation rates over the past 20 years, with various products like patches, gum, and inhalers available to help smokers quit.
Innovative nicotine delivery methods, such as high-dose patches and new forms like drinks and lollipops, are being developed to enhance cessation success and manage withdrawal symptoms.
Nicotine delivery systems.Shiffman, S., Fant, RV., Buchhalter, AR., et al.[2015]
In a study involving over 6,000 smokers, nicotine replacement therapies (gum and patch) showed higher smoking cessation rates in over-the-counter (OTC) settings compared to prescription (Rx) settings, particularly at 6 weeks.
At 6 weeks, 16.1% of OTC gum users and 19.0% of OTC patch users achieved abstinence, compared to only 7.7% and 16.0% for Rx users, respectively, indicating that self-selection of doses in OTC settings may enhance effectiveness.
Real-world efficacy of prescription and over-the-counter nicotine replacement therapy.Shiffman, S., Rolf, CN., Hellebusch, SJ., et al.[2022]
Nicotine replacement therapies (NRTs) significantly increase the chances of quitting smoking, with an overall odds ratio of 1.71 based on a review of 53 trials involving 17,703 patients.
Among different NRT forms, the transdermal patch and inhaled nicotine showed the highest effectiveness, with odds ratios of 2.07 and 3.05 respectively, indicating that these methods may be particularly beneficial for smokers trying to quit.
The effectiveness of nicotine replacement therapies in smoking cessation.Silagy, C., Mant, D., Fowler, G., et al.[2019]

References

Nicotine delivery systems. [2015]
Real-world efficacy of prescription and over-the-counter nicotine replacement therapy. [2022]
The effectiveness of nicotine replacement therapies in smoking cessation. [2019]
Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]
Nicotine inhaler and nicotine patch as a combination therapy for smoking cessation: a randomized, double-blind, placebo-controlled trial. [2019]
A randomised study to assess the nicotine pharmacokinetics of an oral nicotine pouch and two nicotine replacement therapy products. [2022]
[Nicotine preparations and other preparations for smoking cessation]. [2015]
Nicotine gum to help stop smoking. [2016]
Efficacy of a nicotine lozenge for smoking cessation. [2022]
Pharmacotherapy for smoking cessation: pharmacological principles and clinical practice. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Effects of Combined Varenicline With Nicotine Patch and of Extended Treatment Duration on Smoking Cessation: A Randomized Clinical Trial. [2022]
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