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

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

Interventions

OTHER

ECIGS

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.

BEHAVIORAL

mobile contingency management (mCM)

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.

OTHER

Usual brand

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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

  collaborator NIH

• Duke University

  lead OTHER

Principal Investigators

• David Murdoch, MD · Duke University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2018-05-08

Completion

2018-05-08

Countries

• United States

Study Locations