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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
270 Previous Clinical Trials
3,743,405 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
~100 spots leftby May 2025
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