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Nicotine Replacement Therapy

Oral Nicotine Pouches for Tobacco Use

N/A

Waitlist Available

Led By Alison Breland, PhD

Research Sponsored by Virginia Commonwealth University

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 baseline to the end of the session, approximately 4 hours

Awards & highlights

Study Summary

This trial is testing how different types of smokeless tobacco affect nicotine levels and user experience.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to the end of the session, approximately 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to the end of the session, approximately 4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to the end of the session, approximately 4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Plasma nicotine concentration

Other outcome measures

Change emotions and urges

Change in sensations and emotions

Change physical sensations

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Use of oral nicotine pouch - 8 mgExperimental Treatment1 Intervention

On four separate occasions, participants will come to the research center and be asked to use a nicotine pouch or smokeless tobacco provided by the study team two separate times. The nicotine pouches or smokeless tobacco contain different amounts of nicotine. Participants will not know the concentration of nicotine in the nicotine pouch, but they will know the concentration and brand of the smokeless tobacco (it will be their usual brand). All participants will complete all four study conditions. Sessions will be ordered by Latin-square. Participants will not be assigned to arms based on session order and session order will not be recorded as it is not relevant to the study outcomes.

Group II: Use of oral nicotine pouch - 4 mgExperimental Treatment1 Intervention

Group III: Use of oral nicotine pouch - 2 mgExperimental Treatment1 Intervention

Group IV: Use of smokeless tobaccoActive Control1 Intervention

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Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

697 Previous Clinical Trials

22,884,955 Total Patients Enrolled

1 Trials studying Tobacco Use

50 Patients Enrolled for Tobacco Use

National Institute on Drug Abuse (NIDA)NIH

2,464 Previous Clinical Trials

2,618,552 Total Patients Enrolled

30 Trials studying Tobacco Use

6,192 Patients Enrolled for Tobacco Use

Alison Breland, PhDPrincipal InvestigatorVirginia Commonwealth University

9 Previous Clinical Trials

436 Total Patients Enrolled

Media Library

Oral Nicotine Product (Nicotine Replacement Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05280769 — N/A

Tobacco Use Research Study Groups: Use of oral nicotine pouch - 2 mg, Use of oral nicotine pouch - 8 mg, Use of oral nicotine pouch - 4 mg, Use of smokeless tobacco

Oral Nicotine Product (Nicotine Replacement Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05280769 — N/A

Frequently Asked Questions

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

Does the criteria for this research include individuals under 70 years of age?

"To join this medical trial, potential participants must be between the ages 18 and 55. Additional trials are available for people under 18 and those over 65, with 13 studies designed specifically for minors and 35 clinical trials accommodating the elderly."

Answered by AI

Are participants still being invited to join the experiment?

"Affirmative. The clinicaltrials.gov database attests that this trial, which was initiated on August 23rd 2022, is presently enrolling patients. 32 individuals from 1 medical facility are required to participate in the study."

Answered by AI

How many participants have registered for this clinical trial thus far?

"Affirmative. The clinicaltrials.gov database confirms that this research, which was first posted on August 23rd 2022, is actively enrolling volunteers. 32 individuals need to be recruited from one medical facility."

Answered by AI

Am I eligible to partake in this clinical trial?

"This research project is recruiting 32 individuals who are between 18 and 55 years old, use tobacco products, and can provide their informed consent. Crucially, applicants must be judged to be in good health by self-report and agree to abstain from nicotine while participating in the lab sessions according to protocol. Additionally, those using smokeless tobacco must have a 'positive' cotinine cassette result showing nicotine usage."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of an Oral Nicotine Product in Smokeless Tobacco Users

2022. "Effects of an Oral Nicotine Product in Smokeless Tobacco Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05280769.