Optimizing Tobacco Use Treatment for PLWHA

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: National Cancer Institute (NCI); Northwestern University
• Treatments: Nicotine; Varenicline

Criteria

Inclusion Criteria:

• Over the age 18

• Smoke daily for the past 30 days

• Have a confirmed diagnosis of HIV

• Be able to communicate in English

• Be able to provide informed consent

• Agree to live in the geographic area close to one of the sites for at least 7 months

• Be able to use varenicline safely (e.g., no past allergic reaction to varenicline)

• Exhibit viral load of <1000 copies/mL (to ensure ability to meet the trial demands)

Exclusion Criteria:

• Alcohol/Drugs: Current untreated and unstable diagnosis of substance abuse or dependence (if past abuse and if receiving treatment or stable for >30 days, eligible)

• Medication: Current use or discontinuation within last 14 days of quit smoking medications

• Medical: women who are pregnant, planning a pregnancy, or lactating; current diagnosis of unstable and untreated major depression or bipolar disorder (if stable for >30 days, eligible with clinician approval); cancer, heart disease, stroke or myocardial infarction within the past 6 months (unless melanoma and if stable and if clinician approves); uncontrolled hypertension (systolic >160 mm Hg or diastolic >100 mm Hg); history of epilepsy or seizure disorder; history of kidney or liver failure; suicide risk as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

• Other: use of e-cigarettes, chewing tobacco, snuf or snus; currently participating in a smoking cessation program