Nicotine Reduction for Vaping Addiction

Overseen By Wasim Maziak, PhD, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must not be taking: Prescription medications

Disqualifiers: Chronic disease, Psychiatric conditions, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to see if reducing nicotine in e-cigarettes can make them less addictive for young users. Researchers will test different levels of nicotine reduction to find out if it helps decrease usage and dependence. The study focuses on young people because they are increasingly using e-cigarettes and are at high risk of addiction.

Will I have to stop taking my current medications?

Yes, if you regularly use prescription medications (other than vitamins or birth control), you will not be eligible to participate in this trial.

Is reducing nicotine in e-cigarette liquids safe for humans?

The research does not provide specific safety data on reducing nicotine in e-cigarette liquids, but it highlights concerns about users seeking alternative products or modifying their devices, which could have safety implications. ^{1 2 3 4 5}

How does the nicotine reduction treatment for vaping addiction differ from other treatments?

This treatment is unique because it uses varying nicotine concentrations (0%, 3%, 5%) in e-liquids to gradually reduce nicotine dependence, unlike other treatments that may not focus on nicotine reduction or use different methods like nicotine replacement therapy (patches or gum). ^{1 3 6 7 8}

What data supports the effectiveness of the treatment for vaping addiction?

Research suggests that reducing nicotine concentration in e-cigarette liquids may lead users to seek alternative products or adjust their usage, which could potentially help in reducing dependence. Additionally, the combination of nicotine content and flavors plays a role in how people respond to e-cigarettes, indicating that managing these factors could influence vaping habits. ^{1 3 8 9 10}

Who Is on the Research Team?

Wasim Maziak, PhD, MD

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 21-35 who use electronic cigarettes, can attend lab sessions, and have not used e-cigarettes for 12 hours before each visit. Pregnant or breastfeeding women, THC users, those with COVID-19 symptoms or exposure, regular tobacco/nicotine product users in the past year, people with chronic diseases or psychiatric conditions are excluded.

Inclusion Criteria

Generally healthy individuals (determined by physical examination)

Is willing to provide informed consent

I am between 21 and 35 years old.

Exclusion Criteria

You cannot participate if you use homemade or non-commercial e-cigarette liquid or products.

You have a long-term illness or mental health condition.

I have a history of heart disease, blood pressure issues, seizures, or I regularly take prescription medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants use NJOY 5% and 3% nicotine electronic cigarette pods to test the effects of partial nicotine reduction

2 study visits

2 visits (in-person)

Treatment Part 2

Participants use NIDA Standardized Research Electronic Cigarette (SREC) 5% and 0% nicotine pods to test the effects of total nicotine reduction

2 study visits

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 0% nicotine
• 3% nicotine
• 5% nicotine

Trial Overview The study tests how reducing nicotine levels in electronic cigarettes affects addiction and usage among young adults. Participants will try e-cigarettes with different nicotine concentrations: 0%, 3%, and 5% to see if lower nicotine reduces addictiveness as part of a regulatory strategy.

How Is the Trial Designed?

Group I: Electronic cigarette pods (SREC) with 0% nicotine concentration Experimental Treatment 1 Intervention

Participants will complete a lab visit where they will use 0% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

Group II: Electronic cigarette pods (SREC or NJOY) with 5% nicotine concentration Experimental Treatment 1 Intervention

Participants will complete a lab visit where they will use 5% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

Group III: Electronic cigarette pods (NJOY) with 3% nicotine concentration Experimental Treatment 1 Intervention

Participants will complete a lab visit where they will use 3% nicotine electronic cigarette pods ad libitum for up to 60 minutes.

0% nicotine is already approved in United States, European Union for the following indications:

Approved in United States as 0% nicotine e-liquids for:

• Smoking cessation aid
• Nicotine replacement therapy

Approved in European Union as 0% nicotine e-liquids for:

• Smoking cessation aid

Who Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

Published Research Related to This Trial

In a study of 89 regular e-cigarette users, nicotine significantly enhanced psychological reward and craving relief, while flavor increased satisfaction and taste without interacting with nicotine's effects.

The results indicate that e-liquid flavor and nicotine content have independent effects on vaping experiences, suggesting that both factors play distinct roles in influencing e-cigarette use and dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nicotine content and preferred flavor on subjective responses to e-cigarettes: A randomized, placebo-controlled laboratory study. Bremmer, MP., Campbell, AM., Xia, K., et al.[2023]

A study involving 71 e-cigarette users revealed that a 50% reduction in nicotine concentration would likely lead many users to seek alternative e-cigarette products to maintain their nicotine intake.

Participants expressed a range of reactions, including mental preparations and expectations about the change, but were less inclined to switch to traditional tobacco products like cigarettes, suggesting a potential for reduced harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic Cigarette Users' Reactions and Responses to a Hypothetical Nicotine Concentration Reduction in Electronic Cigarette Liquids. Soule, EK., Mayne, S., Snipes, W., et al.[2023]

Juul EU delivers significantly less nicotine compared to Juul US and traditional cigarettes, with a maximum nicotine concentration (Cmax) of only 3.8 ng/ml versus 21.1 ng/ml for Juul US, indicating a lower potential for nicotine delivery.

Due to its lower nicotine delivery, Juul EU may have limited effectiveness in helping smokers quit, as users reported it less effective in relieving urges to smoke compared to Juul US.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products. Phillips-Waller, A., Przulj, D., Smith, KM., et al.[2021]

A study involving 826 adolescents and young adults found that novel nicotine concentration labels, particularly the horizontal stoplight label, significantly improved understanding of nicotine strength compared to traditional mg/mL and percent labels.

The new labels not only conveyed nicotine strength more accurately but also influenced perceptions of addictiveness, with higher concentrations being perceived as more addictive, highlighting the potential for better labeling to inform users about e-cigarette risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Nicotine Concentration Labels Improve Adolescents' and Young Adults' Understanding of the Nicotine Strength of Electronic Nicotine Delivery System Products. Morean, ME., Wackowski, OA., Eissenberg, T., et al.[2023]

In a study involving 14 participants over 3 days, e-liquid flavors significantly influenced nicotine exposure, with strawberry-flavored e-liquid leading to higher systemic nicotine levels compared to tobacco flavor, despite similar amounts inhaled.

Participants reported that usual flavors were more satisfying than strawberry and tobacco, suggesting that flavor preference may affect how users adjust their nicotine intake and experience with e-cigarettes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of e-liquid flavors on nicotine intake and pharmacology of e-cigarettes. St Helen, G., Dempsey, DA., Havel, CM., et al.[2018]

From 2009 to February 2014, there were 225 reported exposures to e-cigarettes at Texas poison centers, with a significant increase over the years, particularly in young children under 5 years old, who accounted for 53% of cases.

Most exposures (87%) were unintentional and primarily occurred through ingestion (78%), with common symptoms including vomiting and nausea, although serious outcomes were rare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarette exposures reported to Texas poison centers. Ordonez, JE., Kleinschmidt, KC., Forrester, MB.[2022]

In a study analyzing 51 e-cigarette products, 23 samples showed significant discrepancies in nicotine concentration, deviating from their labels by more than ±10%, with some variations as extreme as -50.1%.

Out of 39 samples tested for e-liquid volume, 30 also had significant deviations from labeled amounts, highlighting the need for better regulatory oversight to ensure accurate labeling and improve consumer safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Market survey of disposable e-cigarette nicotine content and e-liquid volume. Appleton, S., Cyrus-Miller, H., Seltzer, R., et al.[2022]

The Australian Government has delayed new regulations on the importation of nicotine-containing e-cigarette fluids, raising concerns about the potential risks for the 270,000 daily vapers in Australia who may use high concentrations of nicotine.

There is a call for stricter regulations to limit nicotine concentrations, implement child-resistant packaging, and require clear labeling on nicotine-containing e-fluids to enhance safety and reduce harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine in electronic cigarette fluid: importation pathways to unequal harm. Morgan, J., Jones, A., Kelso, C.[2021]

Among 775 young adult e-cigarette users, 55% reported using cannabis-containing e-liquids, indicating that e-cigarettes are appealing to a wider audience beyond just those trying to quit smoking.

60.8% of e-cigarette users experienced nicotine dependence symptoms, particularly among those who vaped nicotine-containing e-liquids, highlighting the potential risks of poly-nicotine use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Type of e-liquid vaped, poly-nicotine use and nicotine dependence symptoms in young adult e-cigarette users: a descriptive study. Dugas, EN., Sylvestre, MP., O'Loughlin, J.[2023]

The study identified six different organic acids used in nicotine salt formulations of 23 commercially available electronic cigarette liquids, with lactic, benzoic, and levulinic acids being the most common.

The presence and type of these acids may influence the throat sensations, aerosol pharmacology, and overall user experience, highlighting the need for further research on their potential effects on health and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of Nicotine Salts in 23 Electronic Cigarette Refill Liquids. Harvanko, AM., Havel, CM., Jacob, P., et al.[2020]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effects of nicotine content and preferred flavor on subjective responses to e-cigarettes: A randomized, placebo-controlled laboratory study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Electronic Cigarette Users' Reactions and Responses to a Hypothetical Nicotine Concentration Reduction in Electronic Cigarette Liquids. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Nicotine delivery and user reactions to Juul EU (20 mg/ml) compared with Juul US (59 mg/ml), cigarettes and other e-cigarette products. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Novel Nicotine Concentration Labels Improve Adolescents' and Young Adults' Understanding of the Nicotine Strength of Electronic Nicotine Delivery System Products. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Impact of e-liquid flavors on nicotine intake and pharmacology of e-cigarettes. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Electronic cigarette exposures reported to Texas poison centers. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Market survey of disposable e-cigarette nicotine content and e-liquid volume. [2022]

8. Australia pubmed.ncbi.nlm.nih.gov

Nicotine in electronic cigarette fluid: importation pathways to unequal harm. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Type of e-liquid vaped, poly-nicotine use and nicotine dependence symptoms in young adult e-cigarette users: a descriptive study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Characterization of Nicotine Salts in 23 Electronic Cigarette Refill Liquids. [2020]