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Sponsor: University of Pennsylvania
Conditions: HIV/AIDS, Nicotine Dependence
Interventions: Varenicline, Nicotine patch, Standard treatment, Standard treatment + Managed Problem Solving (MAPS) adherence intervention
Countries: United States
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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Key Inclusion 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 Key Exclusion Criteria: * 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
- Chicago, Illinois, United States
- Philadelphia, Pennsylvania, United States