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OpenTrials
Completed

NCT Number: NCT05280769

Effects of an Oral Nicotine Product in Smokeless Tobacco Users

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.

Completed

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • Not providing answers to questions related to inclusion/exclusion criteria
  • 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

Treatment and study plan

oral nicotine pouch - 2 mg

Other

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

oral nicotine pouch - 4 mg

Other

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

oral nicotine pouch - 8 mg

Other

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

Smokeless tobacco

Other

Participant's typical brand of smokeless tobacco

Primary outcomes

  1. Change in Plasma nicotine concentration

    Time frame: Baseline to the end of the session, approximately 4 hours

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

Other outcomes

  1. Change physical sensations

    Time frame: Baseline to the end of the session, approximately 4 hours

    The Direct Effects of Nicotine Questionnaire (DEN) is used to assess the extent to which product use affects participants physically. It consists of 10 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely.

  2. Change in sensations and emotions

    Time frame: Baseline to the end of the session, approximately 4 hours

    The Direct Effects of Smokeless Tobacco (DESLT) Questionnaire is used to assess sensations and emotions associated with smokeless tobacco use. It consists of 12 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely.

  3. Change emotions and urges

    Time frame: Baseline to the end of the session, approximately 4 hours

    The Hughes-Hatsukami Questionnaire (HH) is used to assess the extent to which product use affects a variety of emotions and urges. It consists of 11 items, each of which is scored from 0 - 100 with 0 being not at all and 100 being extremely.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2022
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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