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Low Nicotine Cigarettes Plus Electronic Cigarettes

2019-08-21 20:05:47 | BioPortfolio

Summary

This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).

Description

The specific objective of this study is to recruit a cohort of 240 current exclusive daily SMHC (diagnosed using the MINI International Neuropsychiatric Interview) and to measure a comprehensive battery of behavioral and health indicators at 4, 8, 12 and 16 weeks after being randomized to use either normal nicotine content (NNC) Spectrum cigarettes (11.6 mg nicotine/cigarette) or very low nicotine content (VLNC) Spectrum cigarettes (0.2 mg nicotine/cigarette) while also having access to an electronic cigarette (containing either 0 nicotine or high nicotine e-liquid) in a randomized double-blind, placebo-controlled, 2 by 2 design. All participants will be followed up with a study visit 4 weeks after the final randomized visit to identify whether they have continued to use e-cigs/cigarettes and to assess their motivation in smoking abstinence.

Our central hypothesis is that key markers of harms to health (e.g. urinary NNAL, exhaled CO, measures of addiction, and mental distress) will be significantly improved among SMHC who are provided VLNC cigarettes and high nicotine e-cigs.

Study Design

Conditions

Tobacco Dependence

Intervention

Normal Nicotine Content research cigarettes, High Nicotine e-cigarette, Very Low Nicotine Content research cigarettes, Zero Nicotine e-cigarette

Location

Penn State College of Medicine
Hershey
Pennsylvania
United States
17033

Status

Not yet recruiting

Source

Milton S. Hershey Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-21T20:05:47-0400

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Medical and Biotech [MESH] Definitions

Electronic devices that are designed to provide NICOTINE in the form of an inhaled aerosol. They typically are made in the shape of CIGARETTES in order to simulate the experience of CIGARETTE SMOKING.

Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Chewing gum which contains NICOTINE.

SMOKING vapors produced from ELECTRONIC NICOTINE DELIVERY SYSTEMS.

The SMOKING of CIGARETTES.

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