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Herbal Snuff for Smokeless Tobacco Use
Phase 1
Recruiting
Led By Irina Stepanov, PhD
Research Sponsored by Masonic Cancer Center, University of Minnesota
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants who are not taking any medications that affect relevant metabolic enzymes;
Women who are not pregnant or nursing or planning to become pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
Study Summary
This trial looks at how much of a cancer-causing chemical is produced when people use tobacco products with different levels of a nicotine-like substance.
Who is the study for?
Adult smokeless tobacco users aged 18-65, using at least 3 tins per week for over 6 months, and in good physical and mental health can join. They must not be pregnant or nursing, use other nicotine products or have significant oral health issues. Participants should also not be on medications affecting metabolic enzymes.Check my eligibility
What is being tested?
The study is examining how the body processes nornicotine from herbal snuff to form a carcinogen called NNN. It aims to understand if reducing nornicotine in these products could lower NNN exposure, potentially informing future regulations.See study design
What are the potential side effects?
While this trial focuses on measuring substance levels rather than side effects of a drug intervention, typical risks associated with smokeless tobacco include gum disease, tooth decay, and increased cancer risk.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am not on medication that affects my metabolism.
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I am not pregnant, nursing, or planning to become pregnant.
Select...
I am not on medication that affects my metabolism.
Select...
I am between 18-65 and have used smokeless tobacco regularly for the past 6 months.
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I have used the same smokeless tobacco brand for most of the past 6 months and only that brand for the last 2 weeks.
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I use 3 or more tins of smokeless tobacco weekly for at least 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To investigate endogenous formation of NNN in smokeless tobacco users.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Group 3 (N=15)Experimental Treatment1 Intervention
3.5 µg/g herbal snuff, 5% of the lowest level found in commercial moist snuff
Group II: Group 2 (N=15)Experimental Treatment1 Intervention
70 µg/g herbal snuff, lowest level found in commercial moist snuff (rounded)
Group III: Group 1 (N=15)Experimental Treatment1 Intervention
160 µg/g herbal snuff, median level found in commercial moist snuff
Group IV: Group 4(N=10)Active Control1 Intervention
0 µg/g herbal snuff, control group will use unmodified herbal snuff
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Masonic Cancer Center, University of MinnesotaLead Sponsor
272 Previous Clinical Trials
14,598 Total Patients Enrolled
Irina Stepanov, PhDPrincipal InvestigatorUniversity of Minnesota, Division of Environmental Health Sciences
2 Previous Clinical Trials
161 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your teeth and gums are in bad shape, with noticeable gum recession, cavities, or tooth loss.I have used nicotine replacement or smoking cessation products in the last 2 weeks.I am not on medication that affects my metabolism.I am not pregnant, nursing, or planning to become pregnant.I am not on medication that affects my metabolism.You are in good physical health and good general oral health.You have not smoked or used any other nicotine or tobacco product in the past 2 weeks.You smoke cigarettes or use tobacco regularly (more than once a week), excluding smokeless tobacco products that are placed in the mouth.I am between 18-65 and have used smokeless tobacco regularly for the past 6 months.I have used the same smokeless tobacco brand for most of the past 6 months and only that brand for the last 2 weeks.I do not have major immune, respiratory, kidney, liver, or other disorders that could affect study results.I have used the same smokeless tobacco brand for most of the past 6 months and only that brand for the last 2 weeks.I use 3 or more tins of smokeless tobacco weekly for at least 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Group 3 (N=15)
- Group 2: Group 2 (N=15)
- Group 3: Group 4(N=10)
- Group 4: Group 1 (N=15)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this medical trial accept individuals who are of legal age?
"According to the parameters set forth by this clinical trial, individuals eligible for enrollment must fall between 18 and 65 years of age."
Answered by AI
What is the risk of consuming Herbal Snuff (Smokeless Tobacco)?
"Our team assigned Herbal Snuff a risk level of 1, due to the fact that this Phase 1 trial provides limited data on safety and efficacy."
Answered by AI
How many participants are allowed to join the trial at this time?
"Affirmative. Clinicaltrials.gov confirms that this trial, which was first announced on October 19th 2021 is still looking for candidates to participate. Specifically, the research team seeks 55 individuals from a single medical centre."
Answered by AI
Are there any vacancies for this clinical research endeavor?
"According to clinicaltrials.gov, this experiment is currently in search of participants and was first published on October 19th 2021. The most recent amendment to the study occurred on November 2nd 2022."
Answered by AI
Might I be eligible to partake in this research endeavor?
"This clinical trial seeks 55 eligible candidates who have consumed smokeless tobacco, and are between 18-65 years old."
Answered by AI
Who else is applying?
What state do they live in?
Minnesota
How old are they?
18 - 65
What site did they apply to?
Masonic Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
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