Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04176172

Optimizing Tobacco Use Treatment for PLWHA

Led by University of Pennsylvania · Updated on 2025-12-12

340

Participants Needed

2

Research Sites

341 weeks

Total Duration

On this page

Sponsors

U

University of Pennsylvania

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

The advent of anti-retroviral therapy (ART) for people living with HIV/AIDS (PLWHA) substantially improved life expectancy but has also led to the critical need to address modifiable risk factors associated with cancer and cardiovascular disease, such as tobacco smoking. HIV-infected smokers lose more life-years due to tobacco use than they do to their HIV infection. There have been relatively few studies of tobacco use treatments for PLWHA and systematic reviews show that there are insufficient data to conclude that tobacco dependence interventions that are efficacious in the general population are efficacious for PLWHA. Further, many studies in this area have lacked randomization and a control group, infrequently used an intent-to-treat (ITT) approach and biological verification of tobacco abstinence, and lacked post-treatment follow-up.10 What investigators do know thus far is that behavioral interventions and the nicotine patch yield moderate effects on cessation; and 2 recent placebo-controlled trials - one in France and one by this lab - found that varenicline is safe and effective for treating tobacco use among PLWHA, but yield quit rates that are substantially lower than those reported in the general population. Thus, there is a critical need to rigorously test novel ways to optimize tobacco cessation treatment for smokers with HIV.

CONDITIONS

Official Title

Optimizing Tobacco Use Treatment for PLWHA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years and smoke daily for the past 30 days
  • Confirmed HIV positive with viral load below 1000 copies/mL
  • Reside near one of the study sites for at least 7 months
  • Able to safely use varenicline or nicotine patch
Not Eligible

You will not qualify if you...

  • Untreated and unstable substance abuse or dependence
  • Untreated and unstable major depression, psychosis, or bipolar disorder
  • Suicide risk as measured by the C-SSRS
  • Use or recent discontinuation (within 14 days) of quit smoking medications
  • Cancer, heart disease, stroke, or heart attack within past 6 months without physician approval
  • Uncontrolled high blood pressure
  • History of epilepsy or seizure disorder without physician approval
  • Women who are pregnant, planning pregnancy, or breastfeeding
  • Use of e-cigarettes, chewing tobacco, snuff, or snus
  • Generalized eczema or psoriasis
  • Sensitivity or reaction to nicotine patch or transdermal medications without physician approval
  • Currently in a smoking cessation program

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

2

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

R

Robert Schnoll, PhD

CONTACT

B

Brian Hitsman, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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