Electronic Nicotine Delivery System for Smoking

Recruiting at 25 trial locations

Overseen By Montgomery Hedgecock

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: RAI Services Company

Must not be taking: Antidepressants

Disqualifiers: Heart disease, Diabetes, Cancer, others

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

Compensation: Varies

Number of Visits: 6

Duration: 12 weeks

1950 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if electronic nicotine delivery systems (ENDS), such as e-cigarettes, can help people quit smoking regular cigarettes. Participants will receive an ENDS device and access to various flavored e-liquids, including tobacco, menthol, or non-tobacco/non-menthol, over a three-month period. The trial suits individuals who have smoked at least 10 cigarettes daily for the past month and are open to trying e-cigarettes. Participants should also have smoked regularly for at least a year. As an unphased trial, this study provides a unique opportunity for participants to contribute to understanding alternative smoking cessation methods.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medication for depression.

What prior data suggests that this electronic nicotine delivery system is safe for smoking cessation?

Research shows that electronic nicotine delivery systems (ENDS), like e-cigarettes, carry risks. Studies have found that e-cigarette vapor contains nicotine and tiny particles that can enter the lungs. This vapor may also contain harmful chemicals.

Some reports highlight possible dangers, such as skin irritation and the risk of harm if e-liquids are swallowed or come into contact with the skin. E-liquids can also pose a choking hazard for young children. Although these devices are often seen as safer than regular cigarettes, they are not without risk.

E-cigarettes are regulated by the FDA as alternatives to smoking, meaning they meet certain safety standards but still carry some risks. When considering participation in a trial involving these devices, it is important to weigh the benefits of reducing smoking against these potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these electronic nicotine delivery systems (ENDS) because they offer customizable flavor options, potentially making them a more appealing alternative to traditional cigarettes for smokers looking to quit. Unlike most standard nicotine replacement therapies, such as patches or gum, which typically lack flavor variety, these systems provide choices like tobacco, menthol, and non-tobacco non-menthol flavors, all at a consistent nicotine level of 5%. This flexibility could enhance user satisfaction and adherence, potentially leading to better smoking cessation outcomes.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

This trial will compare different flavor options of electronic nicotine delivery systems (ENDS) to assess their effectiveness in helping participants reduce or quit smoking. Research has shown that e-cigarettes, a type of ENDS, can assist people in cutting down or quitting regular cigarettes. Studies have found that e-cigarettes usually contain fewer harmful chemicals than traditional cigarettes. Some users have reported fewer harmful changes in their mouths, suggesting lower health risks. While evidence on quitting smoking with e-cigarettes remains mixed, many people find them useful for reducing smoking. Overall, e-cigarettes might be a less harmful option than smoking, with some potential to help smokers quit. ^{6 7 8 9 10}

Who Is on the Research Team?

Melissa Tapia, Ph.D.

Principal Investigator

RAIS Service Co

Are You a Good Fit for This Trial?

This trial is for primary smokers who regularly use combustible cigarettes and are interested in trying to quit by using an electronic nicotine delivery system (ENDS) over a three-month period. Specific eligibility criteria details were not provided.

Inclusion Criteria

Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English

Currently smoke at least 10 cigarettes on smoking days in the past 30 days

Smoke cigarettes regularly for at least 12 months

Exclusion Criteria

Persons with pacemakers or other embedded electronic medical devices fitted

Persons who self-report they are allergic/sensitive to cosmetics or fragrances or to any ingredient listed in Vuse commercial products or similar products, including Carvone (L-) and Benzyl alcohol

Participants who have used ENDS, nicotine pouch or smokeless tobacco products on 5 or more days in the past 30 days

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Trial Period

Participants are enrolled, randomized, and begin a one-week trial period to sample available flavors

1 week

1 visit (in-person)

Treatment

Participants use the electronic nicotine delivery system with varying flavor access over a three-month period

12 weeks

4 mandatory visits (in-person) on Day 0, Day 30, Day 60, and Day 90; optional visits on Day 7, Day 14, and Day 21

Follow-up

Participants are monitored for abstinence and product use, with data collected via surveys and puffing topography

3 months

What Are the Treatments Tested in This Trial?

Interventions

• P2611222
• P2613422
• P2615022
• P2615122

Trial Overview

The study is testing whether different flavors of e-liquids (tobacco, menthol, or non-tobacco/non-menthol) used with ENDS affect the ability of cigarette smokers to abstain from smoking their usual brand over ninety days.

How Is the Trial Designed?

Group I: Tobacco, Menthol, Non Tobacco Non Menthol Flavors Active Control 4 Interventions

Participants can choose between tobacco, menthol, and non-tobacco non-menthol flavor variants at one nicotine level (5%).

Group II: Tobacco Flavor Active Control 1 Intervention

Participants can use a tobacco flavor variant at one nicotine level (5%).

Group III: Tobacco and Menthol Flavor Active Control 2 Interventions

Participants can choose between tobacco and menthol flavor variants at one nicotine level (5%).

Who Is Running the Clinical Trial?

RAI Services Company

Lead Sponsor

Trials

43

Recruited

7,700+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/24898072/

Electronic nicotine delivery systems ("e-cigarettes") - PubMed

Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4376316/

Electronic Nicotine Delivery Systems (“E-Cigarettes”)

These data suggest that vapers may compensate for any initial low levels of nicotine or that the absence of smoke irritants allows vapers to inhale more ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4520227/

Electronic nicotine delivery system (electronic cigarette) ...

We sought to systematically review the literature on electronic nicotine delivery systems (ENDS, also called electronic cigarettes) awareness, use, reactions ...

4.

medrxiv.org

medrxiv.org/content/10.1101/2020.10.07.20208355v2.full-text

The Health Impact of Electronic Nicotine Delivery Systems

A small cross-sectional study demonstrated lower numbers of oral cancerous cells (50%) and cellular changes (33%) in e-cigarette users who were ...

5.

researchgate.net

researchgate.net/publication/262885302_Electronic_Nicotine_Delivery_Systems_E-Cigarettes_Review_of_Safety_and_Smoking_Cessation_Efficacy

(PDF) Electronic Nicotine Delivery Systems (“E-Cigarettes”)

Data on the use of e-cigarettes for quitting smoking are suggestive but ultimately inconclusive. Conclusions: Clinicians are advised to be aware ...

6.

fda.gov

fda.gov/tobacco-products/products-ingredients-components/e-cigarettes-vapes-and-other-electronic-nicotine-delivery-systems-ends

E-Cigarettes, Vapes, and other Electronic Nicotine Delivery ...

Get an overview of FDA regulation of e-cigarettes, vapes, and other electronic nicotine delivery systems. You can also find statistics about ...

7.

bhddh.ri.gov

bhddh.ri.gov/sites/g/files/xkgbur411/files/documents/Factsheet-E-Cigs.pdf

Electronic Nicotine Delivery Systems—E-Cigarettes Fact ...

Reality: E-cigarette users inhale and exhale an aerosol that contains nicotine, ultrafine particles that may lodge in the lungs, and low levels of chemicals ...

8.

sigmaaldrich.com

sigmaaldrich.com/CH/en/sds/SIGMA/N3876?srsltid=AfmBOor8deY_edvSy_X7tsfEELF2SwZLTUnHvtPtB9Ul49wyh9N5ckdk

SAFETY DATA SHEET

Hazard Statements. H300 + H310 + H330. Fatal if swallowed, in contact with skin or if inhaled. H315. Causes skin irritation. H318. Causes ...

9.

cdc.gov

cdc.gov/tobacco/e-cigarettes/about.html

About E-Cigarettes (Vapes) | Smoking and Tobacco Use

E-cigarette aerosol is NOT harmless “water vapor.” It can contain harmful and potentially harmful substances. E-cigarette sales in the United ...

10.

betterhealth.vic.gov.au

betterhealth.vic.gov.au/health/healthyliving/e-cigarette-safety

E-cigarette safety

Electronic cigarette components and e-liquid capsules are also a choking hazard for young children. To be safe, it is preferable not to use e-cigarettes or e- ...