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Nicotine Replacement Therapy

Smoking Abstinence for Smoking

N/A
Waitlist Available
Led By Brian Keyser, PhD
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 24 hour
Awards & highlights

Study Summary

This trial will study how biomarkers change in healthy smokers when they switch to using a new nicotine product for 5 days, compared to continuing to smoke their usual cigarettes or quitting smoking altogether.

Who is the study for?
This trial is for generally healthy smokers who want to switch from regular cigarettes to nicotine pouches or try smoking abstinence. Specific details on eligibility criteria are not provided, but typically participants must meet certain health standards and be willing to follow the study's protocol.Check my eligibility
What is being tested?
The study is testing how switching from usual brand cigarettes to different strengths of nicotine pouches (4 mg, 8 mg, 10 mg, and 12 mg) or stopping smoking affects exposure to certain harmful chemicals. Participants will be randomly assigned to one of these new options or continue with their regular smoking habits for five days in a clinic setting.See study design
What are the potential side effects?
Possible side effects may include typical nicotine-related symptoms such as headache, nausea, dizziness, sleep disturbances, and mouth irritation due to the use of nicotine pouches.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hour
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 hour for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
4(methylnitrosamino)1(3pyridyl)1butanol [NNAL] + glucuronides [Total NNAL]
Secondary outcome measures
1Aminonaphthalene [1AN]
1hydroxypyrene [1OHP]
2Aminonaphthalene [2AN]
+10 more

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Smoking AbstinenceExperimental Treatment1 Intervention
Subjects will not use any tobacco or nicotine containing products.
Group II: Continued UB cigarette smokingExperimental Treatment1 Intervention
Subjects will continue use of their Usual Brand Cigarettes.
Group III: Nicotine Pouch P1312914, 4 mg nicotineActive Control1 Intervention
Subjects will be switched to exclusive use of their assigned pouch flavor and strength.
Group IV: Nicotine Pouch P1013215, 8 mg nicotineActive Control1 Intervention
Subjects will be switched to exclusive use of their assigned pouch flavor and strength.
Group V: Nicotine Pouch P1012919, 12 mg nicotineActive Control1 Intervention
Subjects will be switched to exclusive use of their assigned pouch flavor and strength.
Group VI: Nicotine Pouch P1312915, 8 mg nicotineActive Control1 Intervention
Subjects will be switched to exclusive use of their assigned pouch flavor and strength.
Group VII: Nicotine Pouch P1013218, 10 mg nicotineActive Control1 Intervention
Subjects will be switched to exclusive use of their assigned pouch flavor and strength.

Find a Location

Who is running the clinical trial?

RAI Services CompanyLead Sponsor
41 Previous Clinical Trials
7,417 Total Patients Enrolled
33 Trials studying Smoking
4,904 Patients Enrolled for Smoking
Brian Keyser, PhDPrincipal InvestigatorReynolds American

Frequently Asked Questions

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

Does this study include individuals older than 35 years of age?

"Individuals interested in joining this research study must be between 21 and 60 years old to meet the age requirements."

Answered by AI

Can individuals such as myself participate in this clinical study?

"To be eligible for enrollment in this study, candidates must fall within the age bracket of 21 to 60 years and have a history of tobacco use. The trial aims to recruit approximately 200 individuals."

Answered by AI

Are there any available vacancies for participants in this clinical trial?

"As per the information on clinicaltrials.gov, recruitment for this trial is currently closed. The trial was initially posted on July 15th, 2024, with the most recent update made on March 4th, 2024. Despite this specific trial not seeking participants at present, there are over a hundred other ongoing trials open for enrollment."

Answered by AI

At how many different sites is the administration of this trial being managed?

"At the moment, patient enrollment is ongoing at 5 diverse sites. These include locations in Lexington, Springfield, and Knoxville alongside 2 additional undisclosed venues. Opting for the site nearest to you is crucial to reduce travel obligations should you decide to take part."

Answered by AI

Who else is applying?

What site did they apply to?
AMR Knoxville
Pillar Richardson
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Bc I smoke and I could use the money. I've been a cigarette smoker for over 20 years and I'm at a point in my life I need to see what kind of damage I've done, and maybe new ways to abstain. Thank you!
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
CSD231005 Nicotine Pouch Biomarkers of Exposure
2024. "CSD231005 Nicotine Pouch Biomarkers of Exposure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06303115.
~133 spots leftby Dec 2024
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