Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02848586
Study type Interventional
Source Duke University
Contact
Status Terminated
Phase N/A
Start date August 2016
Completion date May 8, 2018

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03661203 - Investigation of the Psychosocial Factors Responsible for the Late Recourse to HIV Testing Within MSM
Completed NCT00381212 - A Pilot Study to Investigate the Safety and Immunologic Activity AGS-004 an Autologous HIV Immunotherapeutic Agent. Phase 1/Phase 2
Not yet recruiting NCT05983536 - The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)
Recruiting NCT04832477 - Assessing the PrEP Care Cascade Among Black Men and Transwomen in the Southeastern US N/A
Active, not recruiting NCT04044586 - HIV and HCV Infections in 2 Communes From the Battambang Province, Cambodia: Prevalence Rates, Viral Strains, and Unsafe Injection Practices (12352 ANRS ROK INVEST)
Completed NCT03218839 - Evaluation of the PrePex Device for Rapid Scale-up of VMMC, Phase 3 Field Implementation Trial With HIV + Adult Males N/A
Active, not recruiting NCT00797030 - Topical Cyclosporine for the Treatment of Dry Eye in Patients Infected With the Human Immunodeficiency Virus Phase 4
Recruiting NCT04088916 - Proviral DNA as a Target for HIV-1 Resistance Analysis
Completed NCT03367130 - Improving Clinic Attendance for Medication Collection Among HIV Positive Individuals in Nepal N/A
Completed NCT04849767 - National Survey About Trajectory and Life Conditions of HIV Trans People in France
Completed NCT05674682 - Seroincidence Study Among Men Who Have Sex With Men and Transgender Women - The ImPrEP Seroincidence Study N/A
Recruiting NCT05174234 - Precariousness and Sexual Vulnerability of People From Haiti Living With or Without HIV in French Guiana
Completed NCT00130819 - Comparison of HIV Clinic-based Treatment With Buprenorphine Versus Referred Care in Heroin-dependent Participants Phase 2
Active, not recruiting NCT04706624 - Screen, Treat and Retain Meth-using People With Opioid Use Disorders at Methadone Clinics N/A
Recruiting NCT03858478 - Initiation of First-line Antiretroviral Treatment With TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the First Clinical Contact in France: Trial IMEA 055 - FAST Phase 4
Completed NCT02154971 - Assessment of Age-related Hearing Loss in HIV-1 Patients
Recruiting NCT03333083 - Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen Phase 3
Recruiting NCT03311945 - Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM Phase 3
Recruiting NCT03795415 - ANRS12373 GUNDO SO - Evaluation of an Empowerment Program for WLHIV in Mali
Completed NCT02003989 - Revealing Increased Axonal Loss in Treated HIV Patients N/A