Nicotine patch for Smoking, Cessation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Smoking, Cessation
Nicotine patch - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare an automated smoking cessation treatment with a more resource-intensive standard treatment to see if the automated treatment is more effective in helping people quit smoking long-term.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 12 Month Follow-Up

12 Month Follow-Up
30 Day Smoking Abstinence
Continuous Smoking Abstinence
Self Reported 24 Hours Smoking Abstinence
Self Reported 7 Day Abstinence Smoking Status
Cotinine

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Standard Treatment
1 of 2
Automated Treatment
1 of 2
Active Control
Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: Nicotine patch · No Placebo Group · N/A

Automated TreatmentExperimental Group · 3 Interventions: Smartphone-delivered automated treatment, Nicotine patch, Nicotine lozenge · Intervention Types: Behavioral, Drug, Drug
Standard TreatmentActiveComparator Group · 3 Interventions: Counseling, Nicotine patch, Nicotine lozenge · Intervention Types: Behavioral, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Smartphone-delivered automated treatment
2017
Completed Phase 4
~40
Nicotine
FDA approved
Nicotine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 month follow-up

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
489 Previous Clinical Trials
122,870 Total Patients Enrolled
15 Trials studying Smoking, Cessation
12,787 Patients Enrolled for Smoking, Cessation
National Cancer Institute (NCI)NIH
12,991 Previous Clinical Trials
41,297,993 Total Patients Enrolled
84 Trials studying Smoking, Cessation
1,093,205 Patients Enrolled for Smoking, Cessation
Damon J Vidrine, Dr.PHPrincipal InvestigatorMoffitt Cancer Center
1 Previous Clinical Trials
500 Total Patients Enrolled
1 Trials studying Smoking, Cessation
500 Patients Enrolled for Smoking, Cessation

Eligibility Criteria

Age 18+ · All Participants · 7 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You smoke at least 5 cigarettes/day.
You have a valid email address.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: October 23rd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Michigan100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Moffitt Cancer Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have lung nodules so I only have 40 percent of lung capacity I was going to the pulmonary specialist to be screened to see if they mastasized they did not. I have chronic bronchitis and smoke a pack a day since I was 14"
What questions have other patients asked about this trial?
  • "I can't afford travel is this a paid trial ?"
How many prior treatments have patients received?
3+100.0%