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Heated Tobacco Product
Product H for 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
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes to 240 minutes
Awards & highlights
Summary
This is a single-center, open-label, randomized, 2-arm, within-arm cross-over study designed to evaluate elements of abuse liability (AL) including subjective effects and physiological measures (pharmacodynamics \[PD\]), and plasma nicotine uptake (pharmacokinetics \[PK\]) during and following ad libitum use of the study investigational products (IPs) by generally healthy smokers.
Eligible Conditions
- Smoking
- Tobacco Use
- Tobacco Smoking
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 minutes to 240 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes to 240 minutes
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUECPL 5-240
Emax PL
Trial Design
2Treatment groups
Experimental Treatment
Group I: Non-menthol smokersExperimental Treatment5 Interventions
Subjects will be randomized to one of ten product use sequences, such that one of the five IPs (A1,B,C,D,N) will be used in each of the five Test Sessions.
Group II: Menthol smokersExperimental Treatment6 Interventions
Subjects will be randomized to one of six product use sequences, such that one of the six IPs (A2,E,F,G,H,N) will be used in each of the six Test Sessions.
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Who is running the clinical trial?
RAI Services CompanyLead Sponsor
41 Previous Clinical Trials
7,542 Total Patients Enrolled
33 Trials studying Smoking
5,029 Patients Enrolled for Smoking
Milly Kanobe, PhDStudy DirectorRAIS
3 Previous Clinical Trials
118 Total Patients Enrolled
3 Trials studying Smoking
118 Patients Enrolled for Smoking
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