Optimizing Tobacco Use Treatment for PLWHA

Description

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

HIV/AIDS, Nicotine Dependence

Study Overview

Study Details

Study overview

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.

Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers with HIV

Optimizing Tobacco Use Treatment for PLWHA

Condition
HIV/AIDS
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University, Chicago, Illinois, United States, 60611

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * \>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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Robert Schnoll, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

2025-08-31