RECRUITING

Optimizing Tobacco Use Treatment for PLWHA

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-02-17
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04176172

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * \>18 years, smoke daily for the past 30 days
  2. * Confirmed HIV+ (exhibit viral load of \<1000 copies/mL)
  3. * Residing in the geographic area close to one of the sites for at least 7 months
  4. * Able to use varenicline/TN patch safely
  1. * Current untreated and unstable diagnosis of substance abuse/dependence
  2. * Current diagnosis of unstable and untreated major depression, psychosis or bipolar disorder
  3. * Suicide risk as measured by the C-SSRS
  4. * Current use or discontinuation within last 14 days of quit smoking medications
  5. * Cancer, heart disease, stroke or MI within the past 6 months requires study physician approval
  6. * Uncontrolled hypertension
  7. * History of epilepsy or seizure disorder requires study physician approval
  8. * Women who are pregnant, planning a pregnancy, or lactating
  9. * Use of e-cigarettes, chewing tobacco, snuff or snus
  10. * Generalized eczema or psoriasis
  11. * A reaction or sensitivity to a nicotine patch or any other transdermal medication requires study physician approval
  12. * Currently participating in a smoking cessation program

Contacts and Locations

Study Contact

Robert Schnoll, PhD
CONTACT
215-746-7143
schnoll@pennmedicine.upenn.edu
Brian Hitsman, PhD
CONTACT
312-503-2074
b-hitsman@northwestern.edu

Principal Investigator

Robert Schnoll, PhD
PRINCIPAL_INVESTIGATOR
University of Pennsylvania

Study Locations (Sites)

Northwestern University
Chicago, Illinois, 60611
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

  • Robert Schnoll, PhD, PRINCIPAL_INVESTIGATOR, University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-17
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2020-02-17
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

  • Smoking Cessation
  • Nicotine Dependence
  • HIV/AIDS
  • Varenicline
  • Nicotine Patch
  • Cigarette Smoking
  • Managed Problem Solving

Additional Relevant MeSH Terms

  • HIV/AIDS
  • Nicotine Dependence