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Nicotine Replacement Therapy

Comprehensive Tobacco Treatment for Smoking Cessation

N/A
Recruiting
Led By Jennifer I Vidrine, Ph.D.
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Current use of smoking cessation medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month follow-up
Awards & highlights

Summary

This trial will test a new smartphone app to help people quit smoking. The app will be based on proven methods to quitting smoking, and the goal is to see if it can help people quit smoking while also being economically impactful.

Who is the study for?
This trial is for English or Spanish speakers who currently smoke more than 5 cigarettes a day, are willing to try quitting within a week of joining, have smoked over 100 cigarettes in their lifetime, own a smartphone compatible with the study's app and have an email address. Pregnant or breastfeeding individuals, those on smoking cessation meds, enrolled in another cessation study or living with someone in this study can't join.Check my eligibility
What is being tested?
The trial is testing how well and cost-effectively a smartphone app helps people quit smoking compared to other methods. Participants will receive automated treatment through the app along with nicotine patches or lozenges and counseling support.See study design
What are the potential side effects?
Possible side effects from interventions may include skin irritation from nicotine patches, mouth problems from lozenges like soreness or heartburn, and typical withdrawal symptoms such as irritability, cravings, or difficulty concentrating.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently using medication to help me stop smoking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 month follow-up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Self Reported 7 Day Abstinence Smoking Status
Secondary outcome measures
30 Day Smoking Abstinence
Continuous Smoking Abstinence
Self Reported 24 Hours Smoking Abstinence
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Automated TreatmentExperimental Treatment3 Interventions
Participants randomized to Automated Treatment (AT) will be given a 10-week supply of nicotine patches and lozenges. AT will also comprise of: 1) 12 proactive treatment videos, delivered weekly, that are tailored on smoking status, motivation, agency, and/or negative affect/stress; 2) 26 weeks of on-demand access to treatment content; 3) 26 weeks of text content
Group II: Standard TreatmentActive Control3 Interventions
Participants randomized to Standard Treatment (ST) will be provided with a 10-week supply of nicotine patches and lozenges. ST participants will be connected with Florida Quitline services and will complete weekly 4-item smartphone assessments electronically for 26 weeks. The weekly assessments consist of questions on smoking status, motivation, self-efficacy, and perceived stress.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone-delivered automated treatment
2017
Completed Phase 4
~40
Nicotine patch
2015
Completed Phase 4
~6130
Nicotine lozenge
2019
Completed Phase 4
~1940

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
549 Previous Clinical Trials
135,210 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,958,901 Total Patients Enrolled
Jennifer I Vidrine, Ph.D.Principal InvestigatorMoffitt Cancer Center

Media Library

Nicotine lozenge (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05004662 — N/A
Smoking Cessation Research Study Groups: Standard Treatment, Automated Treatment
Smoking Cessation Clinical Trial 2023: Nicotine lozenge Highlights & Side Effects. Trial Name: NCT05004662 — N/A
Nicotine lozenge (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05004662 — N/A
Smoking Cessation Patient Testimony for trial: Trial Name: NCT05004662 — N/A
~136 spots leftby Aug 2025
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