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Nicotine Pouches

Product usage order E N D A C B 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
Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English.
Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 minutes to 240 minutes
Awards & highlights

Study Summary

This is a two-site, open-label, randomized, 6-way 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 minutes to 240 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 minutes to 240 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(AUECPL) 5-240: area-under-the-effects curve (AUEC) for Product Liking (PL)
Emax PL: Maximum product liking (PL)

Trial Design

6Treatment groups
Experimental Treatment
Group I: Product usage order N A E B D CExperimental Treatment6 Interventions
Subjects will use each of the 6 products sequentially (N A E B D C) during an evaluation period, followed by a 4 hour Test Session.
Group II: Product usage order E N D A C BExperimental Treatment6 Interventions
Subjects will use each of the 6 products sequentially (E N D A C B) during an evaluation period, followed by a 4 hour Test Session.
Group III: Product usage order D E C N B AExperimental Treatment6 Interventions
Subjects will use each of the 6 products sequentially (D E C N B A) during an evaluation period, followed by a 4 hour Test Session.
Group IV: Product usage order C D B E A NExperimental Treatment6 Interventions
Subjects will use each of the 6 products sequentially (C D B E A N) during an evaluation period, followed by a 4 hour Test Session.
Group V: Product usage order B C A D N EExperimental Treatment6 Interventions
Subjects will use each of the 6 products sequentially (B C A D N E) during an evaluation period, followed by a 4 hour Test Session.
Group VI: Product usage order A B N C E DExperimental Treatment6 Interventions
Subjects will use each of the 6 products sequentially (A B N C E D) during an evaluation period, followed by a 4 hour Test Session.

Find a Location

Who is running the clinical trial?

RAI Services CompanyLead Sponsor
41 Previous Clinical Trials
7,575 Total Patients Enrolled
33 Trials studying Smoking
5,062 Patients Enrolled for Smoking
Milly Kanobe, PhDStudy DirectorRAIS
3 Previous Clinical Trials
151 Total Patients Enrolled
3 Trials studying Smoking
151 Patients Enrolled for Smoking

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
CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches
2022. "CSD201301: Study to Assess Elements of Abuse Liability for Four P13 Nicotine Pouches". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05294497.
~14 spots leftby Apr 2025
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