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Deuterated NNN for Tobacco Exposure

Phase 1

Waitlist Available

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Good physical health with no unstable medical conditions

For female subjects of child bearing potential, not known to be pregnant or nursing, or planning to become pregnant within next 12 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one week post dosing

Awards & highlights

Study Summary

This trial is looking at how people process a cancer-causing toxin found in cigarettes and smokeless tobacco, in hopes of better understanding how to protect people who use tobacco products.

Who is the study for?

This trial is for adults in good physical and mental health who regularly use smokeless tobacco. They must not be pregnant, nursing, or planning pregnancy soon. Participants should not be on medications affecting metabolism enzymes, using other tobacco products, or have unstable medical conditions.Check my eligibility

What is being tested?

The study tests how a toxin called N'-nitrosonornicotine (NNN) found in smokeless tobacco is broken down by users. It involves giving participants a special version of this toxin labeled with deuterium to track its breakdown in the body through blood, saliva, cheek cells, and urine samples.See study design

What are the potential side effects?

Since deuterium is non-toxic and safe there are no expected side effects from the deuterated NNN itself; however routine risks associated with providing blood samples such as bruising or infection may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in good health with no serious or unstable conditions.

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I am not pregnant, nursing, or planning to become pregnant in the next year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week post dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week post dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week post dosing for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Determine extent of α-hydroxylation of NNN as indicated by presence of keto acid 17 and hydroxy acid 22 in plasma

Trial Design

1Treatment groups

Experimental Treatment

Group I: Smokeless tobacco study productExperimental Treatment1 Intervention

Smokeless tobacco product spiked with deuterated NNN.

0 / 2Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,377 Previous Clinical Trials

1,588,246 Total Patients Enrolled

Media Library

Deuterated NNN (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02414477 — Phase 1

Tobacco Exposure Research Study Groups: Smokeless tobacco study product

Tobacco Exposure Clinical Trial 2023: Deuterated NNN Highlights & Side Effects. Trial Name: NCT02414477 — Phase 1

Deuterated NNN (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02414477 — Phase 1

Frequently Asked Questions

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

To what extent is Deuterated NNN danger-free for patients?

"Considering the limited clinical data available to support Deuterated NNN's efficacy and safety, our team assigned it a score of 1."

Answered by AI

Are mature individuals aged 40 or above accepted as participants in this clinical trial?

"As per the prerequisites of this medical trial, participants must fall between 21 and 70 years old to be eligible for enrollment."

Answered by AI

Am I eligible to become a participant in this research project?

"This clinical trial is recruiting 50 participants between 21 and 70 years old who have been exposed to tobacco toxicants. The potential subjects must meet a comprehensive list of criteria, such as being regular users of smokeless tobacco, having good physical health without any unstable medical conditions, possessing stable mental health (as assessed by DSM-IV), not pregnant or breastfeeding for female candidates, and providing written informed consent."

Answered by AI

Is enrollment still available for this research project?

"As indicated on clinicaltrials.gov, this medical trial is no longer recruiting patients for participation. The study was initially posted in April of 2018 and its latest update occurred in March of 2022. Though the current research program has concluded recruitment, there are other active trials that may accept participants at this time."

Answered by AI

Recent research and studies

nJournal

Biochemistry, Biology, and Carcinogenicity of Tobacco-specific <i>n</i>-nitrosamines

Hecht, Stephen S.. 1998. “Biochemistry, Biology, and Carcinogenicity of Tobacco-specific n-nitrosamines”. Chemical Research in Toxicology. American Chemical Society (ACS). doi:10.1021/tx980005y.

BiomarkersJournal

The Ratio of a Urinary Tobacco-specific Lung Carcinogen Metabolite to Cotinine Is Significantly Higher in Passive Than in Active Smokers

Vogel, Rachel I., Steven G. Carmella, Irina Stepanov, Dorothy K. Hatsukami, and Stephen S. Hecht. 2011. “The Ratio of a Urinary Tobacco-specific Lung Carcinogen Metabolite to Cotinine Is Significantly Higher in Passive Than in Active Smokers”. Biomarkers. Informa UK Limited. doi:10.3109/1354750x.2011.598565.

CA: A Cancer Journal for CliniciansJournal

Global Cancer Statistics

Jemal, Ahmedin, Freddie Bray, Melissa M. Center, Jacques Ferlay, Elizabeth Ward, and David Forman. 2011. “Global Cancer Statistics”. CA: A Cancer Journal for Clinicians. Wiley. doi:10.3322/caac.20107.

Harm Reduction JournalJournal