Example Studies

The following studies are “examples” of studies the Grant committee will consider, for Grant Issue, out of the General Fund. These are not committed studies. However, these will remain on the list of possible studies for future funding and may be prioritized along with any other studies the Grant Committee evaluates. These are not listed as commitments for ERF funding. ERF may issue Requests For proposals (RFPs), from Investigators, for these or any other studies the Grant Committee deems to be of priority at any given time.

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1. Do e-cigarette users self-titrate nicotine intake? [Protocol #1]

Purpose

There is a lot of criticism about incorrect labeling of nicotine content in e-cigarette liquids. However, there is controversy over the potential health risk of this mislabeling. Smokers are able to self-adjust (self-titrate) nicotine intake, theory hypothesizes that the same will be true for e-cigarette users. The purpose of this study would be to determine whether e-cigarette users can self-titrate their daily nicotine intake. Participants would be requested to use different nicotine-concentration liquids at separate study periods.

Methods

Investigator would recruit approximately 25 e-cigarette users. Participants would use liquids of different nicotine concentrations (higher and lower levels compared to their regular/daily use) and investigators would assess the cotinine levels before and after each product use. Investigators will be able to determine whether there is any change in total daily intake of nicotine. Therefore, measurements would be performed 4 times for each participant (baseline, post-use of product with higher nicotine levels, post-washout period, post-use of product with lower nicotine levels).

Results/Conclusion

If vapers can self-titrate nicotine intake (similarly to smokers), limited to no change in cotinine levels would be detectable.

Budget

$90,000 approximately.

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2.) Do e-cigarette users self-titrate nicotine intake? [Protocol #2]

Purpose

This would be a second protocol of evaluating self-titration of nicotine intake. At the same time, investigators would evaluate whether high-wattage vaping, which results in higher aerosol yield per puff, is associated with changes in puff patterns (puff duration, nr of puffs).

Methods

Investigators would recruit at least 25 e-cigarette users. Vapers will use the same liquid and atomizer but 2 different wattage levels in a randomized cross-over design on 2 separate days/sessions. Blood samples would be collected repeatedly before and during use of the e-cigarette in each session. The atomizers would be weighed with a precision scale before and after use to see the amount of liquid consumed. The puffing patterns would be evaluated from the stored files of the device (EVIC Supreme).

Results / Conclusion

Nicotine plasma levels and liquid consumption measurements would determine whether vapers change their patterns of use and nicotine intake according to wattage levels.

Budget

Approximately $110,000

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3.) Evaluation of the accuracy of nicotine labeling and presence of tobacco impurities in e-cigarette refill liquids. [Protocol #3]

Purpose

There is a lot of criticism about incorrect labeling of nicotine content in e-cigarette liquids. The purpose of this study would be to evaluate the accuracy of nicotine labeling in a large number of e-liquid refill samples. Additionally, investigators would evaluate nicotine quality by measuring the amount of nicotine impurities in liquids.

Methods

Investigators would obtain approximately 100 samples. From each sample, investigators would obtain 2 different bottles, in order to evaluate the consistency within each company. Nicotine concentration would be measured in all samples (total 200 samples). The amount of nicotine impurities (minor tobacco alkaloids) as well as nitrosamines would also be evaluated and compared to tobacco cigarettes.

Results / Conclusion

It is important to determine both the quality of nicotine and the accuracy in labeling, as factor associated with the quality of the liquids.

Budget

Approximately $140,000

4.) Evaluation of metals degradation and emission to e-cigarette aerosol under realistic conditions [Protocol #4]

Purpose

It is expected to find metals emitted from e-cigarettes, however, it is not currently known where to they come from and which materials may be safer to use. Moreover, it is not known if there may be any elevation in metal emissions from continuous e-cigarette use, since the metals undergo a large number of heating-cooling cycles which could potentially result in metal fatigue. Thus, the purpose of this study would be to evaluate the levels of metals emitted to vapor using different resistance wire materials.

Methods

This would be a laboratory study in which investigators would obtain different wire materials (nichrome, kanthal, titanium, stainless steel, nickel), prepare resistances, and evaluate what is emitted to the vapor by using the same atomizer. Subsequently, an experienced user would use the atomizers for 3-5 days. After that period, an additional analysis on vapor would be performed to evaluate whether use for 5 days results in any significant metal fatigue or corrosion which may result in higher metal emissions.

Results / Conclusion

This study would define which materials, may be better for resistance wires in atomizer heads.

Budget

Approximately $140,000

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