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Nicotine Replacement Therapy

Automated Smoking Treatment for Smoking Cessation

Moffitt Cancer Center, Tampa, FL

Nicotine patch +3 moreN/ARecruitingLed by Damon J Vidrine, Dr.PHResearch 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

HIV positive

Process a smartphone compatible with the project app

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up12 month follow-up

Awards & highlights

No Placebo-Only Group

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.

Eligibility Criteria

Inclusion Criteria

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

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You need to have a smartphone that is compatible with the study app.

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You smoke more than 5 cigarettes a day.

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You have smoked at least 100 cigarettes in your life.

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You are willing to try to quit smoking within one week of starting the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 month follow-up

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

Awards & Highlights

No Placebo-Only Group

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

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 their state's tobacco 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

Nicotine patch

2015

Completed Phase 4

~7450

Smartphone-delivered automated treatment

2017

Completed Phase 4

~40

Nicotine lozenge

2019

Completed Phase 4

~1940

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

527 Previous Clinical Trials

133,535 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,491 Previous Clinical Trials

41,267,069 Total Patients Enrolled

Damon J Vidrine, Dr.PHPrincipal InvestigatorMoffitt Cancer Center

1 Previous Clinical Trials

500 Total Patients Enrolled

Media Library

Nicotine lozenge (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05014282 — N/A

Smoking Cessation Research Study Groups: Standard Treatment, Automated Treatment

Smoking Cessation Clinical Trial 2023: Nicotine lozenge Highlights & Side Effects. Trial Name: NCT05014282 — N/A

Nicotine lozenge (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05014282 — N/A

Smoking Cessation Patient Testimony for trial: Trial Name: NCT05014282 — N/A

Frequently Asked Questions

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

Are any additional participants being enrolled in this scientific experiment?

"Affirmative, the clinicaltrials.gov website outlines that this medical trial has resumed recruitment since its initial post on November 12th 2021 and is currently recruiting 500 patients from a single site."

Answered by AI

Are there any published accounts of research utilizing nicotine patch?

"At the current moment, 71 clinical trials involving a Nicotine patch are underway with 5 of them in Phase 3. Out of 204 locations hosting these studies, most of them can be found in Augusta, Georgia."

Answered by AI

How many participants are there in this investigation?

"Affirmative. The details hosted on clinicaltrials.gov signify that this trial is still searching for eligible participants. It was first posted in November 2021 and last edited nine months later, with a requirement of 500 individuals from one centre."

Answered by AI

Who else is applying?

What state do they live in?

Michigan

How old are they?

18 - 65

What site did they apply to?

Moffitt Cancer Center

What portion of applicants met pre-screening criteria?

Met criteria

How many prior treatments have patients received?

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.

PatientReceived 2+ prior treatments