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Nicotine Replacement Therapy

Harm Reduction for Smoking in People With HIV

N/A
Recruiting
Led By Jonathan Shuter, MD
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 40-79 (the ACC/AHA PCEs risk score is only valid in this age range)
Be older than 18 years old
Must not have
Concurrent receipt of other cessation treatments
Contraindication to varenicline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 9 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find new ways to help people with HIV who smoke cigarettes. Traditional methods to help them quit smoking have not been very successful. The trial suggests a different approach called harm reduction, which

Who is the study for?
This trial is for people aged 40-79 with lab-confirmed HIV who smoke cigarettes and are interested in a web-based tobacco treatment. Participants must have smoked over 100 cigarettes in their lifetime, currently smoke, have internet access, and can read at a 7th-grade level or higher.
What is being tested?
The study tests a harm reduction strategy for smokers with HIV. It includes cutting down on smoking, lung cancer screening, blood pressure and cholesterol control (HR), usual care (TAU), an online cessation program (EX+), plus the offer of Varenicline—a medication to help quit smoking.
What are the potential side effects?
Varenicline may cause nausea, sleep disturbances, headaches, unusual dreams; it's also linked to mood changes or cardiovascular events in some cases. The other interventions involve lifestyle modifications which typically do not have side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 79 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently using other treatments to help me stop smoking.
Select...
I cannot take varenicline due to health reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 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
Biochemically-confirmed 7-day point-prevalence abstinence
Change in American College of Cardiology/Pooled Cohort Equation score (ACC/PCEs)
Change in cigarettes smoked per day (CPD)
+3 more
Secondary study objectives
Change in CD4+ lymphocyte count
Occurrence of Cardiometabolic Clinic appointment
Proportion of participants at target low dose low-density lipoprotein (LDL) cholesterol
+2 more

Awards & Highlights

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: EX+/HRExperimental Treatment3 Interventions
The harm reduction arm (described in detail elsewhere)
Group II: EX+/TAUActive Control3 Interventions
The treatment as usual arm
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Varenicline
2011
Completed Phase 4
~4170
HR
2019
Completed Phase 4
~600

Find a Location

Who is running the clinical trial?

Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
588,214 Total Patients Enrolled
1 Trials studying Tobacco Use
100 Patients Enrolled for Tobacco Use
WestatOTHER
47 Previous Clinical Trials
38,715 Total Patients Enrolled
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,411 Total Patients Enrolled
5 Trials studying Tobacco Use
2,562 Patients Enrolled for Tobacco Use
Truth InitiativeOTHER
18 Previous Clinical Trials
29,436 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
41,111,683 Total Patients Enrolled
19 Trials studying Tobacco Use
10,185 Patients Enrolled for Tobacco Use
Jonathan Shuter, MDPrincipal InvestigatorMontefiore Medical Center
6 Previous Clinical Trials
1,344 Total Patients Enrolled
1 Trials studying Tobacco Use
100 Patients Enrolled for Tobacco Use
~267 spots leftby Mar 2027
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