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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
Approved for 5 Other Conditions
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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

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

Awards & Highlights

Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
277 Previous Clinical Trials
3,743,724 Total Patients Enrolled
2 Trials studying Electronic Cigarette Use
646 Patients Enrolled for Electronic Cigarette Use

Media Library

Nicotine replacement therapy lozenge (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04946825 — Phase 2
Electronic Cigarette Use 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.
Electronic Cigarette Use 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
~90 spots leftby Nov 2025
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