N/A N=359

Novel Determinants and Measures of Smokeless Tobacco Use: Study 1

Smokeless Tobacco Use · Tobacco Dependence

Bottom Line

View on ClinicalTrials.gov: NCT01067586 ↗

Enrolled (actual)

359

Serious AEs

—

Results posted

Dec 2022

Primary outcome: Primary: Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands — 2.4; 2.25; 3.19; 5.51 ug/g

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: Apr 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Extent of Toxicity: Mean of Median Values of NNK+NNN in 7 Smokeless Tobacco Brands	2.4; 2.25; 3.19; 5.51; 2.61; 0.74	—

Summary

The extent of toxicity varies considerably across different brands of smokeless tobacco (ST) products and data suggest that greater toxicity may result in greater health risks. However, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. The goals of this project are to address the following questions: 1. What are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior; 2. What are novel and the best measures of smokeless tobacco use, behavior and exposure; and 3. What are some of the determinants of smokeless tobacco use.

Eligibility Criteria

Inclusion Criteria

Using a consistent and daily amount of ST for the past year;
In good physical health (no unstable medical condition);
Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria

Subjects must not be currently using other tobacco or nicotine products.
Female subjects cannot be pregnant or nursing.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01067586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.