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Electronic Cigarette

blu Disposable B for Healthy Subjects

N/A
Waitlist Available
Research Sponsored by Fontem US LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects must be current smokers (≥10 per day) of combustible cigarettes for at least 6 continuous months before Visit 1 and may be occasional users of e-cigarettes
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
Awards & highlights

Study Summary

This trial is testing whether blu disposable e-cigarettes are more or less addictive than regular cigarettes, and whether they are smoked in the same way.

Who is the study for?
This trial is for current smokers who've been smoking at least 10 cigarettes a day for over 6 months. They can occasionally use e-cigarettes, must have certain levels of nicotine and carbon monoxide in their tests, normal blood pressure and heart rate. Women able to have children must be using birth control.Check my eligibility
What is being tested?
The study compares the effects of five different blu disposable e-cigarettes with regular combustible cigarettes on adult smokers. It measures how much nicotine they take in, how it makes them feel, and how they puff on the products.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include throat irritation, coughing, dizziness or nausea from nicotine intake. The study will monitor these potential reactions compared to usual cigarette use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been smoking more than 10 cigarettes a day for the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes before and at 3, 5, 7, 10, 15, 20, 30, 45, 60, 90, and 120 minutes after the first puff for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Nicotine AUC0-120
Nicotine AUC120-180
Nicotine
+3 more
Secondary outcome measures
Puff topography: puff count
Other outcome measures
Heart rate
Safety Outcome: heart rate after defined use
Safety Outome: diastolic blood pressure after ad libitum use
+3 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: blu Disposable Flavor EExperimental Treatment1 Intervention
Group II: blu Disposable Flavor DExperimental Treatment1 Intervention
Group III: blu Disposable Flavor CExperimental Treatment1 Intervention
Group IV: blu Disposable Flavor BExperimental Treatment1 Intervention
Group V: blu Disposable Flavor AExperimental Treatment1 Intervention
Group VI: Combustible cigaretteActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Fontem US LLCLead Sponsor
2 Previous Clinical Trials
79 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette
2021. "Nicotine Uptake and Abuse Liability Assessments of 5 Blu Disposable Electronic Cigarettes in Comparison to a Combustible Cigarette". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05457634.
~3 spots leftby Dec 2024
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