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Nicotine Replacement Therapy

Varenicline + NRT for Smoking Cessation in PLWHA (HTO Trial)

Phase 3
Recruiting
Led By Robert Schnoll, PhD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
>18 years
>18 years, smoke daily for the past 30 days
Must not have
Uncontrolled hypertension
Current diagnosis of unstable and untreated major depression, psychosis or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will test the efficacy of varenicline, in combination with nicotine replacement therapy (NRT), compared to varenicline alone, for smoking cessation among PLWHA.

Who is the study for?
This trial is for adults over 18 who smoke daily, live near the study sites for at least 7 months, and can safely use varenicline or nicotine patches. Participants must be HIV positive with a viral load under 1000 copies/mL. Those with recent serious health issues, certain mental health conditions, or using other tobacco cessation methods cannot join.
What is being tested?
The study tests if adding Managed Problem Solving (MAPS) to standard treatment helps people living with HIV/AIDS quit smoking more effectively than just standard care alone. It also examines the effectiveness of Varenicline and nicotine patches in this specific group.
What are the potential side effects?
Possible side effects include skin reactions from the patch, nausea, sleep problems, mood changes from Varenicline or MAPS intervention. The severity of side effects may vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 years old.
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I am over 18 and have smoked daily for the last 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My high blood pressure is not under control.
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I do not have untreated major depression, psychosis, or bipolar disorder.
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I have widespread eczema or psoriasis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 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
Point-prevalence abstinence
Secondary study objectives
Continuous abstinence
Prolonged abstinence
Six-month quit rate
+1 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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: NMR-Tailored Medication & Standard Cessation Counseling + MAPSExperimental Treatment3 Interventions
varenicline or nicotine patch plus standard behavioral smoking cessation treatment with Managed Problem Solving adherence intervention
Group II: Varenicline & Standard Cessation CounselingActive Control2 Interventions
varenicline plus standard behavioral smoking cessation treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
Nicotine patch
2015
Completed Phase 4
~6130

Find a Location

Who is running the clinical trial?

Northwestern UniversityOTHER
1,647 Previous Clinical Trials
958,312 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,281 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,928 Previous Clinical Trials
41,017,720 Total Patients Enrolled

Media Library

Nicotine patch (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04176172 — Phase 3
HIV/AIDS Research Study Groups: Varenicline & Standard Cessation Counseling, NMR-Tailored Medication & Standard Cessation Counseling + MAPS
HIV/AIDS Clinical Trial 2023: Nicotine patch Highlights & Side Effects. Trial Name: NCT04176172 — Phase 3
Nicotine patch (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04176172 — Phase 3
HIV/AIDS Patient Testimony for trial: Trial Name: NCT04176172 — Phase 3
~6 spots leftby Dec 2024
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