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Electronic Hookah and Endothelial Cell Function

NCT ID: NCT04133376

Last Updated: 2023-12-01

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

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2023-05-29

Brief Summary

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Electronic nicotine delivery systems (ENDS) are a rapidly growing global epidemic among adolescents and young adults. Unlike other ENDS such as e-cigarettes, e-hookahs are used through traditional water-pipes, allowing the vapor-containing nicotine, propylene glycol, glycerin, and flavorings-to pass through a water-filled basin, potentially altering the vapor, before it is inhaled through the user's mouth. Contributing to e-hookahs popularity is the belief that the flavored smoke is detoxified as it passes through the water-filled basin, rendering e-hookah a safer tobacco alternative. However, an e-hookahs deliver flavored nicotine by creating a vapor of fine particles and volatile organic compounds that could induce vascular toxicity. While e-hookah vaping acutely reduces endothelial function, the specific role of nicotine and the mechanisms by which it may impairs endothelial function remain understudied. The objective of this project is to investigate the specific role of nicotine in mediating the acute effects of e-hookah vaping on endothelial dysfunction.

Detailed Description

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Conditions

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Smoking Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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e-hookah vaping with nicotine

Participants were invited to vape a 30-minute electronic hookah with nicotine vaping session, followed by a 30-minute electronic hookah without nicotine vaping session.

To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.

Group Type EXPERIMENTAL

Electronic hookah vaping with nicotine

Intervention Type OTHER

Participants will be invited to vape a 30-minute session of e-hookah containing nicotine

Electronic hookah vaping without nicotine

Intervention Type OTHER

Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine

e-hookah vaping without nicotine

Participants were invited to vape a 30-minute electronic hookah without nicotine vaping session, followed by a 30-minute electronic hookah with nicotine vaping session.

To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.

Group Type EXPERIMENTAL

Electronic hookah vaping with nicotine

Intervention Type OTHER

Participants will be invited to vape a 30-minute session of e-hookah containing nicotine

Electronic hookah vaping without nicotine

Intervention Type OTHER

Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine

Interventions

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Electronic hookah vaping with nicotine

Participants will be invited to vape a 30-minute session of e-hookah containing nicotine

Intervention Type OTHER

Electronic hookah vaping without nicotine

Participants will be invited to vape a 30-minute session of e-hookah without containing nicotine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 21-39 years old hookah smokers: smoked hookah \>12x in last 12 months
* 21-39 years old e-cigarette users: vaped \>12x in last 12 months
* no history of illicit drugs
* no evidence of cardiopulmonary disease by history/ physical
* no diabetes: fasting blood glucose \<100 mg/dl
* BP\<140/90mmHg
* resting HR\<100 bpm
* BMI\<30kg•m2
* no prescription medication

Exclusion Criteria

* exhaled CO\>10 ppm (smoking non-abstinence)
* positive pregnancy test
* psychiatric illness
Minimum Eligible Age

21 Years

Maximum Eligible Age

39 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tobacco Related Disease Research Program

OTHER

Sponsor Role collaborator

University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Mary Rezk-Hanna, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary Rezk-Hanna, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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University of California, Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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T30IP1013

Identifier Type: -

Identifier Source: org_study_id