Optimizing Tobacco Use Treatment for PLWHA (NCT04176172) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Optimizing Tobacco Use Treatment for PLWHA
United States340 participantsStarted 2020-02-17
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Point-prevalence abstinence
Timeframe: 26 weeks (24 weeks post target quit date)