Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Nicotine Dependence
• Interventions: Other: High nicotine; Other: Medium nicotine; Other: Low nicotine

• Registration Number: NCT01067599
• Lead Sponsor: University of Minnesota

Brief Summary

The research project will determine the level of nicotine in ST products that will lead to the greatest reduction in toxicant exposure

Detailed Description

This is a randomized, multi-site trial determining the effects of switching smokeless tobacco (ST) users to lower toxicant ST products which vary in nicotine levels on biomarkers of exposure and patterns of use. ST users will undergo a two week baseline assessment period and then randomly assigned to one of three oral tobacco products (lower NNK plus NNN product with three different levels of nicotine) for a period of 8-weeks. Follow-up will occur at 9 and 20 weeks.

Study Timeline

• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Study First Posted: 2010-02-11
• Study Start: 2012-03
• Primary Completion: 2015-08
• Study Completion: 2016-10
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

Inclusion Criteria

1. Using a consistent and daily amount of ST with specific nicotine and tobacco-specific nitrosamine (TSNA) levels for the past year;
2. In good physical health (no unstable medical condition);
3. 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High nicotine	High nicotine	Conventional smokeless tobacco product with NNN plus NNK of \<2 μg/gram and nicotine levels of \<3 mg/g wet weight
Medium nicotine	Medium nicotine	Conventional smokeless tobacco product with ) NNN plus NNK of \<2 μg/gram and nicotine levels of 3-5 mg/g wet weight.
Low nicotine	Low nicotine	Conventional smokeless tobacco product with 1) NNN plus NNK of \<2 μg/gram and nicotine levels of \>5 mg/g wet weight

Primary Outcome Measures

Name	Time	Method
1. To determine if switching to ST products with reduced toxicant levels will result in reduction of biomarkers of exposure and toxicity. 2. To determine the nicotine levels of ST that would lead to the greatest reduction in tobacco toxicant exposure.	8 weeks

Secondary Outcome Measures

Name	Time	Method
To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.	8 weeks

Trial Locations

Locations (2)

Oregon Research Institute; 🇺🇸 Eugene, Oregon, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States