A Placebo Controlled Trial of Varenicline for Smoking Among Those With HIV/AIDS
Among people diagnosed with HIV/AIDS, the widespread use of highly active antiretroviral
therapy (HAART) has greatly improved survival rates and changed the leading causes of death,
from AIDS-related diseases (e.g., non-Hodgkin's lymphoma, Kaposi sarcoma), to cardiovascular
disease and lung cancer. As such, addressing modifiable risk factors for disease mortality
among those with HIV/AIDS, including tobacco use, has become a critical priority. To date,
only three smoking cessation clinical trials have been conducted with those with HIV/AIDS
none of which investigated the efficacy of FDA-approved medications for nicotine dependence.
Varenicline is an α4β2 nicotinic acetylcholine receptor partial agonist with greater
efficacy for treating nicotine dependence than bupropion or nicotine patch. Varenicline may
be particularly efficacious for treating nicotine dependence among individuals with HIV/AIDS
given that depression symptoms and cognitive impairment are common in this population,
increase during smoking abstinence and predict smoking relapse, and are significantly
reduced by varenicline. Therefore, the investigators will conduct a randomized,
double-blind, placebo-controlled trial of varenicline with smokers with HIV/AIDS.
Specifically, 310 smokers with HIV/AIDS will be randomized to varenicline plus 9 weeks of
smoking cessation counseling or placebo plus 9 weeks of smoking cessation counseling. The
primary outcome variable for this study will be 7-day biochemically confirmed tobacco
abstinence at weeks 12 and 24. Secondary outcomes include: prolonged abstinence to week 12,
18, and 24 (relapse defined as 7 consecutive days of self-reported smoking, after a 2-week
grace period), continuous abstinence at weeks 12 and 24 (e.g., no smoking between quit day
and follow-up), time to 7-day relapse (no grace period), and lapse and recovery events. The
trial results may support the use of varenicline for the treatment of nicotine dependence
among those with HIV/AIDS, thereby reducing tobacco-related morbidity and mortality in this
population.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Point prevalence tobacco abstinence
7-day biochemically-confirmed tobacco abstinence; biochemically-confirmed with urine cotinine.
Week 12
No
Robert A Schnoll, PhD
Principal Investigator
University of Pennsylvania
United States: Data and Safety Monitoring Board
R01 DA033681-01
NCT01710137
October 2012
June 2017
Name | Location |
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University of Pennsylvania | Philadelphia, Pennsylvania 19104 |