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Nicotine Replacement Therapy

QuitAid for Quitting Smoking

N/A
Recruiting
Led By Melissa Little, PhD, MPH
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 2, and 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if a pharmacist-delivered program called QuitAid can help people in rural Appalachia quit smoking. Participants will receive at least 4 weeks of nicotine patches, with some also

Who is the study for?
This trial is for adult smokers from rural areas in Virginia, Tennessee, Kentucky, and North Carolina who smoke at least 5 cigarettes daily for the past 6 months. Participants must be willing to quit within the next month, own a cell phone, and use nicotine replacement therapy (NRT). Pregnant individuals or those planning pregnancy are excluded.
What is being tested?
The study tests QuitAid—a pharmacist-led coaching program—to see if it helps people stop smoking when used alone or with other treatments like Smokefree TXT messages, Tobacco Quitline calls, and NRT patches or lozenges. Participants will receive different combinations of these treatments randomly to find out which is most effective.
What are the potential side effects?
Possible side effects may include skin irritation from nicotine patches and mouth issues from lozenges such as soreness or heartburn. The texting program and quitline should not have physical side effects but might require time commitment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 2, and 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 2, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Tobacco Abstinence
Secondary study objectives
Adherence to assigned treatment components
Quit Attempts
Self-Reported Tobacco Abstinence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

32Treatment groups
Experimental Treatment
Group I: QuitAid, 8 weeks, Patch, SmokeFree Txt, QuitLineExperimental Treatment4 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
Group II: QuitAid, 8 weeks, Patch, SmokeFree TxtExperimental Treatment3 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
Group III: QuitAid, 8 weeks, Patch, QuitLineExperimental Treatment3 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
Group IV: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineExperimental Treatment5 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
Group V: QuitAid, 8 weeks, Patch + Lozenge, SmokeFree TxtExperimental Treatment4 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
Group VI: QuitAid, 8 weeks, Patch + Lozenge, QuitLineExperimental Treatment4 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
Group VII: QuitAid, 8 weeks, Patch + LozengeExperimental Treatment3 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
Group VIII: QuitAid, 8 weeks, PatchExperimental Treatment2 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
Group IX: QuitAid, 4 weeks, Patch, SmokeFree Txt, QuitLineExperimental Treatment4 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
Group X: QuitAid, 4 weeks, Patch, SmokeFree TxtExperimental Treatment3 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a texting intervention to help quit smoking.
Group XI: QuitAid, 4 weeks, Patch, QuitLineExperimental Treatment3 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline intervention
Group XII: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineExperimental Treatment5 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
Group XIII: QuitAid, 4 weeks, Patch + Lozenge, SmokeFree TxtExperimental Treatment4 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a texting intervention to help quit smoking.
Group XIV: QuitAid, 4 weeks, Patch + Lozenge, QuitLineExperimental Treatment4 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist, 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge, and a Quitline intervention
Group XV: QuitAid, 4 weeks, Patch + LozengeExperimental Treatment3 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and the nicotine lozenge.
Group XVI: QuitAid, 4 weeks, PatchExperimental Treatment2 Interventions
Smoking participants receive QuitAid, a medication therapy management delivered by their pharmacist and 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
Group XVII: 8 weeks, Patch, SmokeFree Txt, QuitLineExperimental Treatment3 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
Group XVIII: 8 weeks, Patch, SmokeFree TxtExperimental Treatment2 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
Group XIX: 8 weeks, Patch, QuitLineExperimental Treatment2 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
Group XX: 8 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineExperimental Treatment4 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
Group XXI: 8 weeks, Patch + Lozenge, SmokeFree TxtExperimental Treatment3 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
Group XXII: 8 weeks, Patch + Lozenge, QuitLineExperimental Treatment3 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
Group XXIII: 8 weeks, Patch + LozengeExperimental Treatment2 Interventions
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
Group XXIV: 8 weeks, PatchExperimental Treatment1 Intervention
Smoking participants receive 8 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
Group XXV: 4 weeks, Patch, SmokeFree Txt, QuitLineExperimental Treatment3 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, a texting intervention to help quit smoking, and a Quitline Intervention.
Group XXVI: 4 weeks, Patch, SmokeFree TxtExperimental Treatment2 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and a texting intervention to help quit smoking.
Group XXVII: 4 weeks, Patch, QuitLineExperimental Treatment2 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch, and a Quitline Intervention.
Group XXVIII: 4 weeks, Patch + Lozenge, SmokeFree Txt, QuitLineExperimental Treatment4 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, a texting intervention to help quit smoking, and a Quitline Intervention.
Group XXIX: 4 weeks, Patch + Lozenge, SmokeFree TxtExperimental Treatment3 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge and a texting intervention to help quit smoking.
Group XXX: 4 weeks, Patch + Lozenge, QuitLineExperimental Treatment3 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge, and a Quitline Intervention.
Group XXXI: 4 weeks, Patch + LozengeExperimental Treatment2 Interventions
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch and lozenge.
Group XXXII: 4 weeks, PatchExperimental Treatment1 Intervention
Smoking participants receive 4 weeks Nicotine Replacement Therapy (NRT) in the form of the nicotine patch.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tobacco Quitline
2020
N/A
~1980

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Who is running the clinical trial?

University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,314,957 Total Patients Enrolled
Melissa Little, PhD, MPHPrincipal InvestigatorUniversity of Virginia
~512 spots leftby Mar 2027
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