Acute Effects of TCIG vs ECIG in PLWH

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2023-05-08

Brief Summary

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Randomized controlled trial of acute use of electronic cigarette or tobacco cigarette on parameters of ventricular repolarization and inflammation/oxidative stress.

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Detailed Description

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On separate days, participants will undergo 3 different exposures: an acute e-cigarette exposure, an acute tobacco cigarette exposure, and a sham (empty e-cigarette) control . Before and after the acute exposure, participants will have blood drawn for inflammation/oxidative stress markers and undergo a 5-minute ECG recording.

Conditions

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E Cigarette Use Vaping Smoking Tobacco Smoking Nicotine Use Disorder Qt Interval, Variation in HIV I Infection Oxidative Stress Inflammation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Crossover with 1 week washout

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

single (outcomes assessor) code

Study Groups

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PLWH smoker

PLWH who smoke will undergo 3 interventions : acute TCIG use, acute ECIG use and acute sham control

Group Type EXPERIMENTAL

TCIG

Intervention Type OTHER

Use a TCIG

ECIG

Intervention Type OTHER

Use an ECIG

sham control

Intervention Type OTHER

Use a sham control (empty ECIG)

Interventions

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TCIG

Use a TCIG

Intervention Type OTHER

ECIG

Use an ECIG

Intervention Type OTHER

sham control

Use a sham control (empty ECIG)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Chronic (\> 1year) TCIG smoker HIV positive Stable ART Viral count non-detectable CD4 \>500

Exclusion Criteria

Known major illness (heart disease, diabetes, lung or liver disease) Daily recreational drug use, including cannabis \>2 alcoholic drinks per day Obesity (\>30 kg/m2) Recent (\<3 months) infection

Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No