NCT05280769

Brief Summary

The purpose of this research study is to find out how three different nicotine pouches and participant's own brand of smokeless tobacco affect blood nicotine levels and how participants feel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 23, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

1.3 years

First QC Date

March 4, 2022

Last Update Submit

September 30, 2024

Conditions

Tobacco Use

Outcome Measures

Primary Outcomes (1)

  • Change in Plasma nicotine concentration

    Blood will be taken multiple times in each session to assess the extent to which product use changes plasma nicotine levels compared to baseline

    Baseline to the end of the session, approximately 4 hours

Other Outcomes (3)

  • Change physical sensations

    Baseline to the end of the session, approximately 4 hours

  • Change in sensations and emotions

    Baseline to the end of the session, approximately 4 hours

  • Change emotions and urges

    Baseline to the end of the session, approximately 4 hours

Study Arms (1)

Single arm design

EXPERIMENTAL

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.

Other: oral nicotine pouch - 2 mgOther: oral nicotine pouch - 4 mgOther: oral nicotine pouch - 8 mgOther: Smokeless tobacco

Interventions

oral nicotine pouch - 2 mgOTHER

"On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor

Single arm design
oral nicotine pouch - 4 mgOTHER

"On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor

Single arm design
oral nicotine pouch - 8 mgOTHER

"On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor

Single arm design
Smokeless tobaccoOTHER

Participant's typical brand of smokeless tobacco

Single arm design

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (determined by self-report)
  • Between the ages of 18-55
  • Willing to provide informed consent, attend the lab sessions and abstain from tobacco/nicotine as required
  • Agree to use designated products according to study protocol
  • Smokeless tobacco users and must report using smokeless tobacco daily. Smokeless tobacco users must have a 'positive' cotinine cassette result to verify nicotine use

You may not qualify if:

  • The following self-reported current, diagnosed medical condition(s): heart-related conditions (e.g., recent heart attack/stroke, coronary heart disease), severe immune system disorders (e.g., HIV/AIDS, multiple sclerosis), respiratory disorders (e.g., COPD, asthma), kidney diseases, liver diseases (e.g., cirrhosis), or seizures
  • Other self-reported current, diagnosed medical conditions (e.g., diabetes, thyroid disease, Lyme disease) may be excluded after consultation with the PI and medical monitor: any medical condition/medication that may affect participant safety, study outcomes, or biomarker data will be excluded based on these consultations
  • Self-reported current, diagnosed psychiatric conditions, and who are currently under the care of a physician for psychiatric conditions, or who report current psychiatric treatment or psychotropic medication use
  • Breast-feeding or pregnant women (pregnancy tested by urinalysis at screening
  • Weigh less than 110 pounds
  • Intend to quit tobacco/nicotine use in the next 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Tobacco, Smokeless

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Tobacco ProductsSmoking DevicesManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Alison Breland, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Single arm study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2022

First Posted

March 15, 2022

Study Start

August 23, 2022

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)