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NCT04176172

Optimizing Tobacco Use Treatment for PLWHA

Active, Not Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Pennsylvania
~340 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:VareniclineNicotine patchStandard treatmentStandard treatment + Managed Problem Solving (MAPS) adherence intervention

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Point-prevalence abstinence
Measured over 26 weeks (24 weeks post target quit date)

Conditions

HIV/AIDS
Nicotine Dependence

Explore related trials

HIV InfectionNicotine Dependence

Where it's being run

2 sites across 2 states
Illinois1
Pennsylvania1

Study leadership

  • Robert Schnoll, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\>18 years, smoke daily for the past 30 days
Confirmed HIV+ (exhibit viral load of \<1000 copies/mL)
Residing in the geographic area close to one of the sites for at least 7 months
Able to use varenicline/TN patch safely

Exclusion

Current untreated and unstable diagnosis of substance abuse/dependence
Current diagnosis of unstable and untreated major depression, psychosis or bipolar disorder
Suicide risk as measured by the C-SSRS
Current use or discontinuation within last 14 days of quit smoking medications
Cancer, heart disease, stroke or MI within the past 6 months requires study physician approval
Uncontrolled hypertension
History of epilepsy or seizure disorder requires study physician approval
Women who are pregnant, planning a pregnancy, or lactating
Use of e-cigarettes, chewing tobacco, snuff or snus
Generalized eczema or psoriasis
A reaction or sensitivity to a nicotine patch or any other transdermal medication requires study physician approval
Currently participating in a smoking cessation program

What this trial measures

  • Point-prevalence abstinence26 weeks (24 weeks post target quit date)

    Participants will be considered abstinent if they report abstinence, not even a puff of a cigarette, for \>7 days prior to week 26 (24 weeks post target quit date) and have an expired carbon monoxide reading of ≤8 parts per million at week 26.