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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 month follow-up
Awards & highlights

Study 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.

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
~7450
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
542 Previous Clinical Trials
134,992 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,167 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of enrollees for this experiment?

"Indeed, clinicaltrials.gov indicates that recruitment for this research is in full swing; the trial was first announced on December 1st 2021 and updated recently November 21st 2022. The study necessitates 500 participants at a single site."

Answered by AI

In what other investigations has Smartphone-based automated treatment been evaluated?

"Presently, there are 71 trials running research into Smartphone-delivered automated treatment with 5 of those studies in their final stage. The majority of these trial sites exist in Greenville, South carolina; yet, 204 locations across the country offer this form of therapy."

Answered by AI

Is the enrollment process open for this research endeavor?

"Correct. Information housed on clinicaltrials.gov confirms this trial is currently recruiting patients, which was initially posted on December 1st 2021 and last updated November 21st 2022. 500 people need to be enrolled at one medical centre for the study's completion."

Answered by AI

Who else is applying?

What state do they live in?
Florida
Wisconsin
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Moffitt Cancer Center
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Im interested in quitting and could use the motivation.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

What is the compensation?
PatientReceived 2+ prior treatments
Recent research and studies
BMC Public HealthJournal
Comparison of an Automated Smartphone-based Smoking Cessation Intervention Versus Standard Quitline-delivered Treatment Among Underserved Smokers: Protocol for a Randomized Controlled Trial
Vidrine, Jennifer I., Ya-Chen Tina Shih, Michael S. Businelle, Steven K. Sutton, Diana Stewart Hoover, Cherell Cottrell-Daniels, Bethany Shorey Fennell, Kristina E. Bowles, and Damon J. Vidrine. 2022. “Comparison of an Automated Smartphone-based Smoking Cessation Intervention Versus Standard Quitline-delivered Treatment Among Underserved Smokers: Protocol for a Randomized Controlled Trial”. BMC Public Health. Springer Science and Business Media LLC. doi:10.1186/s12889-022-12840-7.
clinicaltrials.govStudy
Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers
2021. "Partnering With Food Bank to Provide Tobacco Treatment to Underserved Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05004662.
~170 spots leftby Aug 2025
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