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Other
Filter Ventilation Changes for Smokers
N/A
Recruiting
Led By Dorothy Hatsukami, PhD
Research Sponsored by University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or females at least 21 years of age
Self-report of daily smoking of at least 5 - 25 cigarettes for >= 3 months by self-report
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Awards & highlights
Summary
This trial will test if using different types of filters in cigarettes affects smoking behavior and exposure to harmful substances like nicotine and carbon monoxide in menthol smokers who switch to non-menthol cigarettes. Participants
Who is the study for?
This trial is for menthol cigarette smokers who are interested in switching to non-menthol cigarettes. Participants will need the ability to conduct telehealth visits and send samples by mail.
What is being tested?
The study is testing how changing from menthol to non-menthol cigarettes with different filter ventilation affects smoking behavior and exposure to harmful substances, using remote monitoring and sample collection.
What are the potential side effects?
Since this trial involves regular tobacco products, side effects may include typical risks associated with smoking such as coughing or increased blood pressure but are not directly caused by the interventions of the study.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am at least 21 years old.
Select...
I have been smoking 5 to 25 cigarettes daily for at least 3 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
feasibility- drop-out rate
feasibility-date collection
Secondary outcome measures
Cigarettes smoked
carbon monoxide change
cotinine change
Other outcome measures
Mean of the Fagerström Test for Nicotine Dependence (FTND)
Mean of the subscales of the modified Cigarette Evaluation Questionnaire (mCEQ)
Perceived health risks
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Menthol cigarettes smokers group 2Experimental Treatment1 Intervention
Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to minimally ventilated non-menthol cigarettes
Group II: Menthol cigarettes smokers group 1Experimental Treatment1 Intervention
Smokers regularly using menthol cigarettes (at least 80% of the time) who meet eligibility criteria will enter 2 weeks of monitoring of usual brand smoking. Randomized to ventilated non-menthol cigarettes
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Who is running the clinical trial?
University of MinnesotaLead Sponsor
1,413 Previous Clinical Trials
1,561,353 Total Patients Enrolled
11 Trials studying Smoking
28,288 Patients Enrolled for Smoking
Dorothy Hatsukami, PhDPrincipal InvestigatorUniversity of Minnesota
10 Previous Clinical Trials
2,414 Total Patients Enrolled
2 Trials studying Smoking
566 Patients Enrolled for Smoking
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