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

Who is this study for? Smokers with HIV
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Behavioral
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>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

Locations
United States
Illinois
Northwestern University
RECRUITING
Chicago
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Robert Schnoll, PhD
schnoll@pennmedicine.upenn.edu
215-746-7143
Backup
Brian Hitsman, PhD
b-hitsman@northwestern.edu
312-503-2074
Time Frame
Start Date: 2020-02-17
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 340
Treatments
Active_comparator: Varenicline & Standard Cessation Counseling
varenicline plus standard behavioral smoking cessation treatment
Experimental: NMR-Tailored Medication & Standard Cessation Counseling + MAPS
varenicline or nicotine patch plus standard behavioral smoking cessation treatment with Managed Problem Solving adherence intervention
Authors
Robert Schnoll
Related Therapeutic Areas
Sponsors
Collaborators: Northwestern University, National Cancer Institute (NCI)
Leads: University of Pennsylvania

This content was sourced from clinicaltrials.gov