Nicotine Dependence, Tobacco Use Disorder
Conditions
Keywords
Biomarkers of tobacco exposure, Smokeless Tobacco
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.
Interventions
OTHERLow nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
OTHERMedium nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
OTHERHigh nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Sponsors
National Cancer Institute (NCI)
National Institute on Drug Abuse (NIDA)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| To determine the extent to which varying low nicotine ST products leads to compensatory tobacco use. | 8 weeks |
Countries
United States
Outcome results
None listed