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The purpose of this study is to determine if using e-cigarettes (ECIG) rather than regular tobacco cigarettes alters lung inflammation in people with HIV. The study is also interested in asking subjects their opinion on the use of ECIG and how they make them feel. This study is for research purposes only and is not intended to treat asthma or HIV or to modify tobacco use.
Title: Effects of e-cigarettes (ECIGs) on pulmonary inflammation and behavior in HIV infected smokers
Purpose of the Study: Even though smoking is the leading cause of preventable disease and deaths in the U.S., millions of Americans continue to smoke cigarettes, including 40-70% of all HIV-infected patients. The advent of e-cigarettes as a potential risk reduction strategy to reduce traditional tobacco cigarette use and promote smoking cessation is attractive. The goal of the proposed research is to gain an understanding of the cellular and inflammatory mechanisms that occur in the lung of HIV-infected smokers who transition from conventional tobacco cigarettes to e-cigarettes and to characterize the effects of substituting e-cigarettes on withdrawal, craving and neurocognition. These efforts will provide first in kind data on the effects of ECIGs in this study population.
Background & Significance: While rates of cigarette smoking are gradually decreasing in the US, the burden of tobacco abuse among people living with HIV remains undisputedly high with prevalence estimates two to three times higher than the general population (42.4% vs. 17.8%). Although ECIGs likely contain significantly fewer numbers of toxicants compared to combustible cigarettes, it is unclear whether ECIG are less harmful than their traditional tobacco counterparts or if they can reduce withdrawal, craving and neurocognitive deficits that precipitate relapse to conventional cigarettes. The biological effects of ECIG on lung health have not yet been sufficiently characterized due the relatively nascent nature of the field. While combustible tobacco use induces oxidant stress in the airways of healthy smokers, little work to date has established the effect of ECIG use on oxidant stress in human airways. Transitioning the HIV-infected smoker from combustible tobacco to ECIG may decrease lung oxidative stress, improve lung function and decrease withdrawal symptoms and deficits in neurocognition commonly seen with tobacco withdrawal.
Design & Procedures: HIV-infected persons will be recruited from the Duke Infectious Diseases Clinic. For this pilot study, 15 willing subjects will receive ECIGs and 5 control subjects will continue to smoke their chosen usual brand of combustible cigarettes (UB). Each group will receive either ECIG or UB for a total of 4 weeks and undergo pulmonary and behavioral assessments during this period. In order to facilitate participants' successful transition to ECIG, a mobile contingency management (mCM) procedure (discussed below) will be used to provide monetary reinforcement for biochemically verified abstinence from combustible cigarettes. Participants in the UB group will also undergo mCM procedures, but contingencies will differ. After 4 weeks, the ECIG group will be allowed to transition back to their chosen combustible cigarette product for an additional 2 weeks with additional pulmonary and behavioral assessments. All subjects will undergo three respiratory assessments in the Duke Clinical Research Unit (DCRU). The first respiratory assessment will occur at study visit 1 (V1) to establish baseline measures of lung function, oxidative stress, and systemic inflammation. Pulmonary assessments will be repeated again 4wks after transition to ECIG or continued UB use (V4). A final respiratory assessment (V5) will occur 2 weeks after stopping ECIG or after 6 weeks of continued UB use to measure changes relative to baseline lung function, oxidative stress, and inflammation. Neuro-cognitive and behavioral visits will occur at respiratory visits as well as 2 weeks after ECIG transition / continued UB use (V3).
Selection of Subjects: Inclusion / Exclusion Criteria are provided below.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
ECIGS, mobile contingency management (mCM), Usual brand
Not yet recruiting
Published on BioPortfolio: 2016-07-29T04:08:21-0400
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