Effects of an Oral Nicotine Product in Smokeless Tobacco Users

Tobacco Use Clinical Trial

Official title:

Effects of an Oral Nicotine Product in Smokeless Tobacco Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280769
• Other study ID #: HM20018418
• Secondary ID: U54DA036105
• Status: Completed
• Phase: N/A
• Start date: August 23, 2022
• Est. completion date: November 28, 2023

Study information

• Verified date: April 2024
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: November 28, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

Other:
• oral nicotine pouch - 2 mg
"On" brand oral nicotine pouch with 2 mg of protonated nicotine in "original" flavor
• oral nicotine pouch - 4 mg
"On" brand oral nicotine pouch with 4 mg of protonated nicotine in "original" flavor
• oral nicotine pouch - 8 mg
"On" brand oral nicotine pouch with 8 mg of protonated nicotine in "original" flavor
• Smokeless tobacco
Participant's typical brand of smokeless tobacco

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change physical sensations	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.	Baseline to the end of the session, approximately 4 hours
Other	Change in sensations and emotions	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.	Baseline to the end of the session, approximately 4 hours
Other	Change emotions and urges	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.	Baseline to the end of the session, approximately 4 hours
Primary	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