Optimizing tobacco treatment for people living with HIV/AIDS
Testing Novel Pharmacogenetic and Adherence Optimization Treatments to Improve the Effectiveness of Smoking Cessation Treatments for Smokers With HIV
This study is trying to find out if personalized medication and support can help people living with HIV/AIDS quit smoking more effectively.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 340 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT04176172 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve smoking cessation strategies for individuals living with HIV/AIDS (PLWHA) who are also nicotine dependent. It will evaluate the effectiveness of personalized medication selection based on the nicotine metabolite ratio (NMR) and the Managed Problem Solving (MAPS) adherence intervention. The study will utilize a rigorous methodology, including randomization and biological verification of tobacco abstinence, to assess the impact of these interventions on smoking cessation rates among PLWHA. By addressing the high smoking rates in this population, the trial seeks to enhance overall health outcomes and reduce the risks associated with tobacco use.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who smoke daily, are confirmed HIV positive, and reside near one of the study sites.
Not a fit: Patients with untreated substance abuse issues, unstable mental health conditions, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this trial could significantly improve smoking cessation rates among people living with HIV/AIDS, leading to better health outcomes and reduced risk of tobacco-related diseases.
How similar studies have performed: While there have been few studies specifically targeting tobacco cessation in PLWHA, existing literature suggests that personalized and structured interventions can yield moderate success, indicating potential for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Chicago, Illinois and 1 other locations
- Northwestern University — Chicago, Illinois, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Robert Schnoll, PhD — University of Pennsylvania
- Study coordinator: Robert Schnoll, PhD
- Email: schnoll@pennmedicine.upenn.edu
- Phone: 215-746-7143
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.