Actively Recruiting
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
Eligibility Criteria
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
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
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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
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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