HIV Seropositivity Clinical Trial
Official title:
Effects of E-cigarettes (ECIGs) on Pulmonary Inflammation and Behavior in HIV Infected Smokers
Verified date | December 2019 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 10 |
Est. completion date | May 8, 2018 |
Est. primary completion date | May 8, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: 1. Self-reported smoking of =10 cigarettes/day for >2yrs 2. Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter 3. Have expired CO concentrations of =10ppm or morning urinary cotinine >100ng/ml (as measured with NicAlert) - If present in the afternoon with CO concentration >10ppm then no cotinine test - If less than <10 then urinary continine 4. No serious quit attempt in the prior 3 months. This includes use of any FDA approved smoking cessation medication (varenicline, bupropion [used specifically as a quitting aid], patch, gum, lozenge, inhaler, and nasal spray) in the past 3 months as an indication of treatment seeking 5. No plans to quit in the next 3 months (set quit date, designated method, etc.) 6. Participants must be interested in substituting their normal combustible tobacco products with ECIG for 4 weeks 7. Willing and able to give informed consent and adhere to visit/protocol schedules 8. Reported method of birth control for at least 3 months prior to enrollment for women of child bearing potential 9. Read and write in English HIV-positive patients must meet the following additional inclusion criteria: 10. Currently receive HIV care at the Duke Infectious Diseases Clinic 11. Receiving stable ART treatment (i.e., no ART class changes or changes in dose in response to poor virological control) for >9 months with viral loads <200 copies/mL Exclusion Criteria: 1. Alcohol intoxication measured by positive BAL (any detectable level) 2. Acute psychiatric symptoms (e.g. mania, hallucinations) preventing completion of the study procedures 3. Current use of nicotine replacement or other pharmacotherapy for smoking cessation 4. Positive pregnancy test for women (pregnant women will be referred for smoking cessation) and/or nursing women 5. Use of other tobacco products (e.g. chew tobacco, snuff) on >10 of the past 30 days will exclude patients to ensure they are primarily cigarette smokers 6. Use of hand-rolled, roll your own cigarettes 7. Use of marijuana or cigars >2 times/week will be excluded from the study. Subjects using marijuana =2 times/week will be required to refrain for the duration of the protocol. 8. Positive urine drug screen other than marijuana or currently prescribed medications. 9. Known allergy to propylene glycol or vegetable glycerin (potential constituents of ECIG) 10. Use of an ECIG for 5 or more within 30 days or any use in the past 7 days 11. Patients with a formal clinical or spirometry diagnosis of co-existing inflammatory airway conditions of COPD and/or asthma or underlying illnesses that may result in altered lung function (bronchiectasis, prior surgical lung resection, extensive cavitary infectious disease, etc.) 12. An ED visit or inpatient admission for a primary respiratory diagnosis or treatment with antibiotics within 60 days of enrollment 13. History of any systemic or inhaled corticosteroids within 3 months 14. Regular substance abuse or inpatient treatment for these in the past 6 months 15. Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator |
Country | Name | City | State |
---|---|---|---|
United States | Duke University Medical Center | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute of Allergy and Infectious Diseases (NIAID) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Weeks 1, 6, and 8 | |
Secondary | Change in sputum 8-isoprostane | Weeks 1, 6, and 8 | ||
Secondary | Change in nitrate/nitrite | Weeks 1, 6, and 8 | ||
Secondary | Change in sputum inflammatory cytokines | Weeks 1, 6, and 8 | ||
Secondary | Change in withdrawal, as measured by questionnaire | Weeks 1, 2, 4, 6, 8 | ||
Secondary | Change in craving, as measured by questionnaire | Weeks 1, 2, 4, 6, 8 | ||
Secondary | Change in neurocognition, as measured by questionnaire | Weeks 2, 6, 8 |
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