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NCT07598136 · RAI Services Company

A Study to Determine the Effects of ENDS Flavor Availability on Abstinence Within Smokers

What this study is about

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the experimental product) within their assigned study treatment group$1 over a three-month (ninety-day) period.

View original scientific description

The overall purpose of this study will be to assess primary combustible cigarette users' abstinence from smoking their usual brand of combustible cigarettes at the end of the study, when provided with an electronic nicotine delivery system (ENDS) power unit (2) and varying levels of access to tobacco-flavored, menthol-flavored, mint, or non-tobacco/non-menthol/non-mint-flavored cartridge-based e-liquids (collectively referred to as the investigational product) within their assigned study arm over a three-month (ninety-day) period.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Able to read, understand, and are willing to sign an Informed Consent Form (ICF) and complete questionnaires written in English.
  • Generally healthy male or female, between 21 and 65 years of age, inclusive, at the time of consent.
  • All female (assigned at birth) and those who identify as "intersex" or "unknown candidate" participants who agree to take the pregnancy test on site and receive a negative result, and who affirm at the SEV that they are not pregnant or intending to become pregnant.
  • Currently smoke at least 5 CC on smoking days in the past 30 days.
  • Smoke CC on 15 or more of the past 30 days.
  • Smoked at least 100 factory-made CC in their lifetime prior to the SEV.
  • Indicate a willingness to use ENDS.
  • Own and regularly use a smartphone (iOS or Android) with internet access to download a study application to access surveys and the capability to receive notifications.
  • Agree to participate in the study and to abide by the study restrictions and requirements, as described in the ICF.

Exclusion criteria

  • Female participants who are pregnant or breastfeeding or planning to become pregnant or start breastfeeding within the next 6 months based on self-report.
  • Male participants who self-report they are not willing to use a barrier method of contraception (e.g., a condom with spermicide) or refrain from donating sperm from the signing of the ICF until the end of the study, unless they have undergone a vasectomy or are abstinent from heterosexual intercourse, or their female partner was not able to bear children.
  • Female participants who self-report not using adequate methods to prevent pregnancy.
  • Persons with pacemakers or other embedded electronic medical devices fitted.
  • Participants who self-report having an unstable heart condition, severe hypertension or diabetes.
  • Persons who self-report they are allergic/sensitive to cosmetics or fragrances, or any ingredient listed in commercial e-cigarette products.
  • Participants who self-report poor physical or mental health.
  • Participants who have used ENDS, nicotine pouch, smokeless tobacco (i.e., chewing tobacco, snus, or snuff) products, heated tobacco products, other combustible products and other oral nicotine products (tablets, gums and lozenges) on 5 or more days in the past 30 days.
  • Participants who have used a nicotine replacement therapy (NRT) product or a prescription drug to help stop smoking (e.g., varenicline, bupropion) in the past 30 days.
  • Participants who do not own a smartphone that meets the minimum technical requirements to run the survey app.
  • Employee of a company that manufactures tobacco or ENDS products.
  • Persons who are personally, have household members, or have close family or friends in litigation with a company that manufactures tobacco or ENDS products.
  • Have taken part in a tobacco/nicotine research study in the past 30 days.

Where

  • Maitland, Florida
  • Atlanta, Georgia
  • St Louis, Missouri
  • Raleigh, North Carolina
  • Philadelphia, Pennsylvania
  • Dallas, Texas
  • Houston, Texas

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations

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1 of 1280 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Maitland

Florida

Location available
RECRUITING

Atlanta

Georgia

Location available
RECRUITING

St Louis

Missouri

Location available
RECRUITING

Raleigh

North Carolina

Location available
RECRUITING

Philadelphia

Pennsylvania

Location available
RECRUITING

Dallas

Texas

Location available
RECRUITING

Houston

Texas

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Looking for Smoking Treatment in Maitland?

Join others in Florida exploring innovative treatment options through clinical research

Smoking Treatment Options in Maitland, Florida

If you're searching for Smoking treatment in Maitland, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Maitland, Atlanta, St Louis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Smoking. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Florida
Now Enrolling
Up to 1280 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Smoking?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Smoking

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Smoking Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07598136. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.