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Nicotine Replacement Therapy

Nicotine Replacement Therapy for Quitting Smoking

Phase 2
Waitlist Available
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment).
Awards & highlights

Study Summary

This trial will test whether nicotine replacement therapy, with or without text message support, can help young adult smokers who also use e-cigarettes to quit smoking.

Who is the study for?
This trial is for young adults who smoke tobacco cigarettes and use e-cigarettes, and are interested in quitting smoking. It's designed to help them stop using both or just tobacco cigarettes.Check my eligibility
What is being tested?
The study tests nicotine replacement therapy (NRT) with patches or lozenges combined with text message support against text message support alone. Participants will be randomly assigned to one of four groups, aiming to quit either combustible cigarettes only or both types of products.See study design
What are the potential side effects?
Possible side effects from NRT can include skin irritation from patches, insomnia, headache, nausea, dizziness, racing heartbeat from the nicotine intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment).
This trial's timeline: 3 weeks for screening, Varies for treatment, and the 3-month follow up (ie., end of treatment) and 6-month follow up (3 months after the end of treatment). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Therapeutic procedure
Biochemically confirmed 7-day point-prevalence cigarette abstinence
Self-reported 7-day point-prevalence cigarette abstinence
Secondary outcome measures
Any attempts to quit combustible cigarettes
Attempts to quit combustible cigarettes lasting 24 hours or more
Biochemically confirmed prolonged 30-day abstinence
+3 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Quit cigarettes, but continue using e-cigarettes, with text support.Experimental Treatment1 Intervention
Participants in this arm will be instructed to quit tobacco cigarettes with text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
Group II: Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text supportExperimental Treatment3 Interventions
Participants in this arm will be instructed to quit tobacco cigarettes with nicotine replacement therapy (patches and lozenges) and text message support. In addition, these participants will be encouraged to continue using electronic cigarettes to help them quit smoking tobacco cigarettes.
Group III: Quit cigarettes and quit e-cigarettes with text support.Experimental Treatment1 Intervention
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with text message support.
Group IV: Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support.Experimental Treatment3 Interventions
Participants in this arm will be instructed to quit tobacco cigarettes and quit electronic cigarettes with nicotine replacement therapy (patches and lozenges) and text message support.

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
266 Previous Clinical Trials
3,743,301 Total Patients Enrolled

Media Library

Nicotine replacement therapy lozenge (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04946825 — Phase 2
Nicotine Addiction Research Study Groups: Quit cigarettes, but continue using e-cigarettes, with nicotine replacement therapy and text support, Quit cigarettes and quit e-cigarettes with nicotine replacement therapy and text support., Quit cigarettes, but continue using e-cigarettes, with text support., Quit cigarettes and quit e-cigarettes with text support.
Nicotine Addiction Clinical Trial 2023: Nicotine replacement therapy lozenge Highlights & Side Effects. Trial Name: NCT04946825 — Phase 2
Nicotine replacement therapy lozenge (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04946825 — Phase 2

Frequently Asked Questions

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

Are there any other precedent cases for the use of nicotine replacement therapy lozenge?

"Currently, there are a total of 74 clinical trials testing the efficacy of Nicotine replacement therapy lozenges. 5 of those studies have progressed to Phase 3 trials. The majority of these research operations are based in Green Bay, Wisconsin; though, 209 locations across the United States are running similar investigations."

Answered by AI

Does this research include elderly people as participants?

"The target patient population for this research are young adults aged 18-29."

Answered by AI

For which patient population is this clinical trial designed?

"This study, which is looking for 390 young adults that smoke cigarettes and use e-cigarettes with the intention of quitting tobacco, has the following requirements: Aged 18-29, Must smoke tobacco cigarettes, Uses electronic cigarettes, Interested in quitting tobacco."

Answered by AI

What are the dangers associated with taking Nicotine replacement therapy lozenges?

"While Phase 2 trials don't have any data supporting efficacy, there is some evidence that nicotine replacement therapy lozenges are safe. Therefore, Power team members gave it a score of 2."

Answered by AI

How many individuals can enroll in this research project?

"Yes, as indicated by the clinicaltrials.gov website, this trial is open for recruitment. This particular study was posted on 6/27/2021 and updated on 9/2/2021. The researchers conducting this trial need 390 participants total, which will be gathered from 1 location."

Answered by AI

Are we still able to enroll patients in this clinical trial?

"Yes, this clinical trial is recruiting patients as of September 2nd, 2021. The original posting date was June 27th, 2021."

Answered by AI

What goals does this trial hope to achieve?

"The primary metric by which success will be measured for this clinical trial, taking place over a 3 month period, is self-reported 7-day point-prevalence cigarette abstinence. Additionally, the investigators will also look at biochemically confirmed prolonged 30-day abstinence, self-reported prolonged 30-day abstinence, and attempts to quit combustible cigarettes lasting 24 hours or more as secondary metrics of success."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Quit Smoking Study for People Who Use E-Cigarettes
Elias Klemperer 2021. "Quit Smoking Study for People Who Use E-Cigarettes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04946825.
~104 spots leftby Apr 2025
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