Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

Nicotine Dependence Clinical Trial

Official title:

Novel Determinants and Measures of Smokeless Tobacco Use: Study 2 Effects of Switching Levels of Nicotine and TSNA in Products on Smokeless Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067599
• Other study ID #: 1R01CA141531-01
• Secondary ID: 1R01CA141531
• Status: Completed
• Phase: N/A
• First received: February 10, 2010
• Last updated: February 22, 2018
• Start date: March 2012
• Est. completion date: October 2016

Study information

• Verified date: February 2018
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Other:
• Low nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
• Medium nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
• High nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Cancer Institute (NCI), National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use.		8 weeks