An interventional study of ECIGS and mobile contingency management (mCM) in Lung Inflammation and HIV Seropositivity, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-11.
Sponsored by Duke University · Not applicable, Interventional, and Basic science
The purpose of this study is to determine if using e-cigarettes (ECIG) rather than regular tobacco cigarettes alters lung inflammation in people with and without 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 16% of persons in the general population and 40-70% of all HIV-infected patients. In contrast to the relatively known adverse effects of combustible cigarettes, the rapid emergence of e-cigarettes have raised numerous questions regarding their health effects which may be amplified in vulnerable populations and those already immunocompromised such as HIV-infected patients. 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 their behavioral and neurocognitive effects. These efforts will provide first in kind data on the effects of ECIGs in this study population and provide valuable data to develop needed regulatory policies.
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. 16%). Although ECIGs likely contain significantly fewer numbers of toxicants compared to combustible cigarettes, it is not yet clear whether ECIG are less harmful than their traditional tobacco counterparts and what, if any, effects they have on behavior and neurocognitive functioning. 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 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: 15 HIV-infected adults will be recruited from the Duke Infectious Diseases Clinic. In addition, 5 HIV-negative adults will be recruited from the community through flyers. 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 examine pulmonary and behavioral effects of ECIG in the absence of combustible cigarette use, a mobile contingency management (mCM) procedure will be used to provide monetary reinforcement for biochemically verified discontinuation of the use of 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 arm assignment (V1) to establish baseline measures of lung function, oxidative stress, and systemic inflammation. Pulmonary assessments will be repeated again 4 weeks 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 take place in Duke South or at the Center for Addiction Science and Technology (CfAST) and occur at Visit 2 (mCM transition), and respiratory visits (V4 \& V5) as well as 2 weeks after ECIG transition/ continued UB use (V3)
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This study's enrollment of 10 is below the median of 106 across 1,247 interventional studies indexed under Pneumonia.
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Have expired CO concentrations of ≥10ppm or morning urinary cotinine >100ng/ml (as measured with NicAlert)
Read and write in English
HIV-positive patients must meet the following additional inclusion criteria:
Exclusion Criteria:
Subjects will receive e-cigarettes for a total of 4 weeks. A mobile contingency management (mCM) procedure will be used to provide monetary reinforcement for biochemically verified abstinence from combustible cigarettes. After 4 weeks, subjects will be allowed to transition back to their chosen combustible cigarette product for an additional 2 weeks. Respiratory assessments will occur at study arm assignment (Visit 1) to establish baseline measures of lung function, oxidative stress, and systemic inflammation, repeated again 4 weeks after transition to ECIG (Visit 4) and again 2 weeks after stopping ECIG (Visit 5). Neuro-cognitive and behavioral assessments will occur at Visits 2, 3, 4 and 5.
Other: ECIGS · Behavioral: mobile contingency management (mCM)
Subjects will receive their usual brand of combustible cigarettes for a total of 4 weeks. A mobile contingency management mCM procedure will be used. Respiratory assessments will occur at study arm assignment (Visit 1) to establish baseline measures of lung function, oxidative stress, and systemic inflammation, repeated again 4 weeks later (Visit 4) and again 2 weeks later (Visit 5). Neuro-cognitive and behavioral assessments will occur at Visits 2, 3, 4 and 5.
Behavioral: mobile contingency management (mCM) · Other: Usual brand
15 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. A mobile contingency management (mCM) procedure 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 DCRU.
Also known as: Port Royale
mCM procedures are a novel smoking cessation tool previously used in the field by our colleagues in the Beckham research group. This equipment is part of a procedure called "mobile contingency management" or "mCM". The participant will use a study smartphone to record his/her CO levels and moods at random times of the day and to verify his/her cigarette usage. The mCM program will reward the participant for each CO level and data transmitted to the study team. The study team will provide detailed information and training to allow them to participate in this part of the study.
The usual brand of cigarettes is the control group in this study. 5 participants will be allowed to continue using their "usual brand" of combustible cigarette in this arm of the study.
Changes in sputum glutathione concentration
Sputum will be obtained by each participant and a sputum supernatant prepared. Glutathione concentration will be measured in the sputum supernatant.
Time frame: Weeks 1, 6, and 8
Change in sputum 8-isoprostane
Time frame: Weeks 1, 6, and 8
Change in nitrate/nitrite
Time frame: Weeks 1, 6, and 8
Change in sputum inflammatory cytokines
Time frame: Weeks 1, 6, and 8
Change in withdrawal, as measured by questionnaire
Time frame: Weeks 1, 2, 4, 6, 8
Change in craving, as measured by questionnaire
Time frame: Weeks 1, 2, 4, 6, 8
Change in neurocognition, as measured by questionnaire
Time frame: Weeks 2, 6, 8
Plan to share: No
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This study is terminated, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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