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E-Cigarettes for Tobacco Smoking

N/A
Waitlist Available
Research Sponsored by RAI Services Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Generally healthy adult males or females, 21-60 years old, verified with government-issued photo ID
Must be a current smoker of manufactured menthol and/or non-menthol cigarettes, has smoked at least 100 cigarettes in their lifetime, and smoked on at least 20 days out of the past 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial studies how adults in the U.S. use Cartridge-based ENDS products (e-cigarettes) in their daily lives. Subjects choose from 3 categories: tobacco, menthol, and non-tobacco-non-menthol flavors and report their usage of e-cigarettes and other tobacco products in an electronic diary.

Who is the study for?
This study is for U.S. adult smokers aged 21-60 who smoke more than 5 cigarettes daily and have done so on most days in the past month. Participants must not be planning to quit soon, be in good physical and mental health, and not use other nicotine delivery systems regularly.Check my eligibility
What is being tested?
The trial tests various flavors of a cartridge-based electronic nicotine delivery system (ENDS) over six weeks. Smokers are randomly assigned to tobacco, menthol, or non-tobacco-non-menthol flavors and report their usage along with any cigarette smoking through an eDiary.See study design
What are the potential side effects?
While specific side effects aren't listed here, ENDS can potentially cause throat irritation, coughing, dry mouth or throat, dizziness due to nicotine intake variations from traditional cigarettes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a healthy adult between 21 and 60 years old.
Select...
I currently smoke regularly and have smoked at least 100 cigarettes in my life.
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I agree to participate in the study for 8 weeks, follow all requirements, and not share the study treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CPD mean percent reduction
Number and proportion of subjects who reduce their cigarettes per day (CPD).

Trial Design

3Treatment groups
Active Control
Group I: Tobacco FlavorActive Control4 Interventions
Can choose between 2 different tobacco flavor variants at 2 different nicotine levels (1.5% and 5%)
Group II: Menthol FlavorActive Control4 Interventions
Can choose between 2 different menthol flavor variants at 2 different nicotine levels (1.5% and 5%)
Group III: NTNM FlavorActive Control4 Interventions
Can choose between 2 different non tobacco/non menthol flavor variants at 2 different nicotine levels (1.5% and 5%)

Find a Location

Who is running the clinical trial?

RAI Services CompanyLead Sponsor
41 Previous Clinical Trials
5,772 Total Patients Enrolled
Kristen Jordan, PhDStudy DirectorRAIS

Media Library

Tobacco Flavor Clinical Trial Eligibility Overview. Trial Name: NCT05960305 — N/A
Tobacco Smoking Research Study Groups: Tobacco Flavor, Menthol Flavor, NTNM Flavor
Tobacco Smoking Clinical Trial 2023: Tobacco Flavor Highlights & Side Effects. Trial Name: NCT05960305 — N/A
Tobacco Flavor 2023 Treatment Timeline for Medical Study. Trial Name: NCT05960305 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age requirement for this experimentation preclude anyone who has surpassed 25 years of life?

"To be eligible for this clinical trial, individuals must fall between the ages of 21 and 60."

Answered by AI

Who is eligible to participate in this experiment?

"To meet the requirements for this study, applicants should be tobacco smokers between 21 to 60 years of age. In total, 1845 individuals will be recruited."

Answered by AI

How many healthcare institutions are implementing this research project?

"12 different medical centres are recruiting patients for this clinical trial, including Non Sago Ft Lauderdale in Fort Lauderdale, SAGO Orlando in Orlando and Non Sago Tampa in Tampa. Additionally, there is a plethora of other locations taking part too."

Answered by AI

Are there any available opportunities for prospective participants in this clinical trial?

"Per clinicaltrials.gov, the posting for this medical trial was made on September 4th 2023 and updated most recently on July 21st 2023. Unfortunately, there is currently no recruitment process to join this study; however, 38 other studies are actively recruiting participants at present."

Answered by AI

Who else is applying?

What site did they apply to?
Sago St. Louis
Other
Non-Sago Las Vegas
Sago Philadelphia
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I've tried EVERYTHING! Smoked since 1964 & I NEED to Quit. I need more information about this trial before making a commitment that I’m confident in.
PatientReceived no prior treatments
Cigarette oder on my clothes, skin, breath and all the money I have spent over the years.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers
2023. "CSD201204 An Actual Use Study of P12 Electronic Nicotine Delivery System Among U.S. Adult Smokers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05960305.
All > Paid Studies Las Vegas
~1165 spots leftby Apr 2025
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