Effects of E-cigarettes (ECIGs) on Pulmonary Inflammation and Behavior in HIV Infected Smokers

NCT02848586 | Terminated

• 2 other identifiers: Pro00066481P30AI064518
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Inflammation; HIV Seropositivity

Keywords

HIV; ECIGS; e-cigarettes; lung inflammation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in sputum 8-isoprostane

  Weeks 1, 6, and 8

• Change in nitrate/nitrite

  Weeks 1, 6, and 8

• Change in sputum inflammatory cytokines

  Weeks 1, 6, and 8

• Change in withdrawal, as measured by questionnaire

  Weeks 1, 2, 4, 6, 8

• Change in craving, as measured by questionnaire

  Weeks 1, 2, 4, 6, 8

Study Arms (2)

ECIGS

ACTIVE COMPARATOR

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)

Usual brand

ACTIVE COMPARATOR

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

Interventions

ECIGS OTHER

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

ECIGS

mobile contingency management (mCM) BEHAVIORAL

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.

ECIGS; Usual brand

Usual brand OTHER

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.

Usual brand

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Self-reported smoking of ≥10 cigarettes/day for \>2yrs
• Smoke regular filtered cigarettes or machine-rolled cigarettes with a filter
• 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
• 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
• No plans to quit in the next 3 months (set quit date, designated method, etc.)
• Participants must be interested in substituting their normal combustible tobacco products with ECIG for 4 weeks
• Willing and able to give informed consent and adhere to visit/protocol schedules
• Reported method of birth control for at least 3 months prior to enrollment for women of child bearing potential
• Read and write in English
• Currently receive HIV care at the Duke Infectious Diseases Clinic
• 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

You may not qualify if:

• Alcohol intoxication measured by positive BAL (any detectable level)
• Acute psychiatric symptoms (e.g. mania, hallucinations) preventing completion of the study procedures
• Current use of nicotine replacement or other pharmacotherapy for smoking cessation
• Positive pregnancy test for women (pregnant women will be referred for smoking cessation) and/or nursing women
• 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
• Use of hand-rolled, roll your own cigarettes
• 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.
• Positive urine drug screen other than marijuana or currently prescribed medications.
• Known allergy to propylene glycol or vegetable glycerin (potential constituents of ECIG)
• Use of an ECIG for 5 or more within 30 days or any use in the past 7 days
• 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.)
• An ED visit or inpatient admission for a primary respiratory diagnosis or treatment with antibiotics within 60 days of enrollment
• History of any systemic or inhaled corticosteroids within 3 months
• Regular substance abuse or inpatient treatment for these in the past 6 months
• Poorly controlled concomitant conditions that pose additional procedure risk as determined by the investigator

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Pneumonia; HIV Seropositivity; Vaping

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Smoking; Behavior

Study Officials

• David Murdoch, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: July 28, 2016
• Study Start: August 1, 2016
• Primary Completion: May 8, 2018
• Study Completion: May 8, 2018
• Last Updated: July 11, 2023

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)