E-Cigarette Flavor Impact for ENDS Flavors

(RVA Flavors Trial)

Overseen By Caroline O Cobb, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Unstable medical condition, Illegal drug use, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

71 Participants Needed

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that E-Cigarette Flavor Impact for ENDS Flavors is an effective treatment?

The available research does not provide specific data supporting the effectiveness of E-Cigarette Flavor Impact for ENDS Flavors as a treatment. The articles focus on patient-reported outcomes and their role in evaluating medical products, but they do not directly address the effectiveness of E-Cigarette Flavor Impact for ENDS Flavors. Therefore, there is no direct comparison or data available in the provided information to support its effectiveness as a treatment. ^{1 2 3 4 5}

What safety data exists for e-cigarettes and vaping products?

Existing safety data on e-cigarettes and vaping products (ENDS) includes studies on their design features, nicotine and glycols content, and potential regulatory challenges. There are reports of acute adverse events from liquid nicotine exposure, particularly in young children. User modifications to ENDS can change product toxicity, and regulatory actions may influence these behaviors. ENDS devices vary in their potential to generate toxic chemicals, with higher power devices being more hazardous. Poison center data also provides insights into ENDS-related exposures. ^{6 7 8 9 10}

Is the treatment in the trial 'E-Cigarette Flavor Impact for ENDS Flavors' a promising treatment?

The trial focuses on the impact of e-cigarette flavors, which are a major reason why young people start using e-cigarettes. Flavors like fruit are especially popular and linked to trying e-cigarettes first. This suggests that flavors play a big role in making e-cigarettes appealing, especially to youth. However, the trial does not suggest that flavors are a promising treatment for any health condition. ^{6 11 12 13 14}

What is the purpose of this trial?

This study aims to better understand how the availability of electronic nicotine delivery system (aka electronic cigarettes) flavors (e.g., menthol, tobacco) impacts tobacco use behaviors, toxicant exposure, and abuse liability among African American menthol smokers.

Research Team

Andrew J Barnes, PhD

Principal Investigator

Virginia Commonwealth University

Caroline O Cobb, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for African American menthol cigarette smokers over 21 who smoke more than 5 cigarettes a day and have used electronic cigarettes in the last month. Participants should not plan to quit smoking soon, must be able to complete surveys, and have a mobile phone with text/data plans. Those using marijuana or other drugs frequently, pregnant women, or those with serious health issues can't join.

Inclusion Criteria

ENDS use in the past 3 months

Identify as Black/African American (single or multi-race)

Have used ≥5 cigarettes per day for ≥1 year

Exclusion Criteria

I am not willing to use electronic nicotine delivery systems in the trial.

I have not had any serious or unstable health issues in the last year.

Report any other illegal drug use in the past 30 days

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive electronic nicotine delivery systems with different flavor options for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tobacco product administration and assessment

Trial Overview The study examines how different flavors of electronic cigarettes like menthol affect tobacco use habits, exposure to harmful substances, and potential for abuse among participants.

Participant Groups

Group I: Unflavored Experimental Treatment 1 Intervention

Unflavored - where only unflavored liquid is available for electronic nicotine delivery systems

Group II: Tobacco Experimental Treatment 1 Intervention

Tobacco - where only tobacco flavored liquid is available for electronic nicotine delivery systems

Group III: Menthol+Tobacco Active Control 1 Intervention

Menthol+Tobacco - where both menthol and tobacco flavored liquids for electronic nicotine delivery systems are available to choose from

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Patient-reported outcome measures are becoming increasingly important in clinical care and research, and their integration with electronic health records (EHRs) can enhance patient-centered care and comparative effectiveness research.

The article proposes a framework for standardizing the collection of patient-reported outcomes within EHRs, which could lead to more consistent and comprehensive data collection for improving patient care and research outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research. Wu, AW., Kharrazi, H., Boulware, LE., et al.[2022]

The FDA has established the Study Endpoints and Label Development (SEALD) group to improve the evaluation of patient-reported outcomes (PROs) in clinical trials, ensuring that drug approvals and promotional claims are based on reliable measures.

The article outlines FDA-recommended methods for defining a 'responder' in PRO measures, which is crucial for determining meaningful changes in patient outcomes and enhancing the precision of clinical trial results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interpreting patient-reported outcome results: US FDA guidance and emerging methods. McLeod, LD., Coon, CD., Martin, SA., et al.[2022]

In a study of 433 patients with rheumatoid arthritis who had inadequate responses to adalimumab or etanercept, 84.4% reported satisfaction with the golimumab injection experience at week 8, compared to only 63.4% satisfaction with their previous treatments.

Patients continuing with golimumab through week 44 experienced significantly less discomfort and pain during injections compared to their prior tumor necrosis factor antagonist medications, indicating a better overall injection experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept. Dehoratius, RJ., Brent, LH., Curtis, JR., et al.[2018]

Incorporating patient-reported outcomes (PROs) into clinical trials is essential for accurately assessing the benefits of new medical products, such as symptom relief and improved functioning.

Standardizing the measurement of PRO endpoints is crucial for translating these benefits into labeling claims, which can guide physicians and patients in making informed treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims. Coons, SJ., Kothari, S., Monz, BU., et al.[2022]

In a review of 180 products authorized by the European Medicines Agency from 2008 to 2012, patient-reported outcomes (PROs) were used as primary endpoints in 37% of cases, highlighting their significant role in evaluating treatment efficacy.

Despite the presence of PROs in nearly half of the products studied, the overall usage of PROs, clinician-reported outcomes (CROs), and laboratory-reported outcomes (LROs) remained static, indicating a need for improved transparency and reporting practices in regulatory submissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012). Bansal, D., Bhagat, A., Schifano, F., et al.[2022]

Electronic nicotine delivery systems (ENDS), like e-cigarettes, were introduced as a safer alternative for smokers, but their use has expanded to young people and non-smokers, raising concerns about unintended health risks.

The design and power of ENDS devices can significantly affect their safety, with higher power devices potentially being more hazardous, highlighting the need for ongoing research to understand the benefits and risks associated with these products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clearing the Haze: What Do We Still Need to Learn about Electronic Nicotine Delivery Systems? Fucito, LM., Malinosky, H., Baldassarri, SR., et al.[2023]

Between 2012 and 2017, there was a nearly sixfold increase in calls to the British Columbia Poison Centre regarding exposures to electronic nicotine delivery systems (ENDS), primarily due to accidental ingestions in young children, particularly those aged 4 years or less.

Of the 186 unique exposures recorded, 46.8% resulted in reported symptoms, highlighting the need for regulatory measures to reduce children's access to ENDS and improve product safety through better labeling and packaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic cigarette exposures reported to the British Columbia Drug and Poison Information Centre: an observational case series. Choi, A., Le, M., Rahim, T., et al.[2022]

Many electronic nicotine delivery systems (ENDS) contain varying amounts of nicotine that do not match the concentrations labeled on the cartridges, indicating a lack of consistency and reliability in these products.

The presence of chemicals like propylene glycol and glycerol in ENDS raises safety concerns, as limited information is available about the actual contents, which could affect both recreational users and those attempting to quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective. Cheah, NP., Chong, NW., Tan, J., et al.[2022]

A study involving in-depth interviews with 13 adult ENDS users revealed that modifications to devices, such as coils and e-liquids, are commonly made to enhance nicotine delivery, flavor, and vapor production.

Despite a reported decline in modifications due to manufacturer changes, hobbyists still engage in extensive modifications, and regulatory actions by the FDA could inadvertently encourage users to revert to more extensive modifications, impacting safety and product toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' Modifications to Electronic Nicotine Delivery Systems (ENDS): Interviews with ENDS Enthusiasts. Li, Y., Fairman, RT., Churchill, V., et al.[2020]

In 2018, an estimated 885 cases of liquid nicotine poisoning among children under 5 were treated in U.S. emergency departments, indicating a concerning trend in exposure.

The majority of these poisoning cases (90%) were treated and released, with ingestion being the most common route of exposure (99.4%), highlighting the need for increased public awareness and safety measures regarding liquid nicotine products.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery system (ENDS) liquid nicotine exposure in young children presenting to US emergency departments, 2018. Chang, JT., Rostron, BL.[2022]

A study involving 30 college-aged JUUL users found that preferred flavours significantly enhanced user satisfaction, enjoyment, and motivation to use the product compared to a classic tobacco flavour.

Despite both flavour conditions leading to increased nicotine levels, the preferred flavour resulted in a much higher likelihood of continued use, suggesting that restricting flavours could help reduce ENDS appeal among young users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of flavour manipulation on ENDS (JUUL) users' experiences, puffing behaviour and nicotine exposure among US college students. Vargas-Rivera, M., Ebrahimi Kalan, M., Ward-Peterson, M., et al.[2023]

In a study of 1,489 adult ENDS users, sweet flavors were the most popular, making up 76.2% of the flavors used, while menthol/mint and tobacco flavors were significantly less common.

Users of sweet-flavored liquids tended to use lower nicotine concentrations and higher wattages, suggesting that flavor choice influences device settings and potentially user behavior, which has important implications for regulatory policies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Device and liquid characteristics used with sweet, menthol/mint, and tobacco ENDS liquid flavors: The population-based VAPER study. Crespi, E., Hardesty, JJ., Nian, Q., et al.[2023]

A study of 1549 youth aged 13-18 revealed that fruit flavors are the most popular among e-cigarette users, significantly influencing their choice to try e-cigarettes as their first tobacco product.

Youth who preferred fruit flavors were twice as likely to have tried e-cigarettes first, while those who preferred menthol/mint flavors were less likely, highlighting the strong association between flavor preferences and e-cigarette experimentation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of youth vaping flavor preferences. Groom, AL., Vu, TT., Kesh, A., et al.[2020]

In a study of 4909 adults who were established users of electronic nicotine delivery systems (ENDS), 9.8% reported having chronic obstructive pulmonary disease (COPD), with the highest prevalence (19.9%) among users of tobacco-flavored ENDS.

Tobacco-flavored ENDS were found to have a significantly higher association with self-reported COPD (adjusted odds ratio of 2.05) compared to non-tobacco flavors, suggesting a potential link between tobacco flavor use and respiratory health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of flavored electronic nicotine delivery system (ENDS) use with self-reported chronic obstructive pulmonary disease (COPD): Results from the Population Assessment of Tobacco and Health (PATH) study, Wave 4. Shi, H., Tavárez, ZQ., Xie, Z., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Measure once, cut twice--adding patient-reported outcome measures to the electronic health record for comparative effectiveness research. [2022]

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

Interpreting patient-reported outcome results: US FDA guidance and emerging methods. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Satisfaction with Subcutaneous Golimumab and its Auto-Injector among Rheumatoid Arthritis Patients with Inadequate Response to Adalimumab or Etanercept. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012). [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Clearing the Haze: What Do We Still Need to Learn about Electronic Nicotine Delivery Systems? [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

Electronic cigarette exposures reported to the British Columbia Drug and Poison Information Centre: an observational case series. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Electronic nicotine delivery systems: regulatory and safety challenges: Singapore perspective. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Users' Modifications to Electronic Nicotine Delivery Systems (ENDS): Interviews with ENDS Enthusiasts. [2020]

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

Electronic nicotine delivery system (ENDS) liquid nicotine exposure in young children presenting to US emergency departments, 2018. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Effect of flavour manipulation on ENDS (JUUL) users' experiences, puffing behaviour and nicotine exposure among US college students. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Device and liquid characteristics used with sweet, menthol/mint, and tobacco ENDS liquid flavors: The population-based VAPER study. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Correlates of youth vaping flavor preferences. [2020]

14. Greece pubmed.ncbi.nlm.nih.gov

Association of flavored electronic nicotine delivery system (ENDS) use with self-reported chronic obstructive pulmonary disease (COPD): Results from the Population Assessment of Tobacco and Health (PATH) study, Wave 4. [2021]