Novel Determinants and Measures of Smokeless Tobacco Use: Study 2

University of Minnesota (UMN)

Status: Completed

Conditions: Nicotine Dependence; Tobacco Use Disorder

Treatments: Other: Low nicotine; Other: Medium nicotine; Other: High nicotine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01067599

1R01CA141531-01

1R01CA141531 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 278 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

278 participants in 3 patient groups

Low nicotine

Active Comparator group

Description:

Conventional smokeless tobacco product with 1) NNN plus NNK of \<2 μg/gram and nicotine levels of \>5 mg/g wet weight

Treatment:

Other: Low nicotine

Medium nicotine

Active Comparator group

Description:

Conventional smokeless tobacco product with ) NNN plus NNK of \<2 μg/gram and nicotine levels of 3-5 mg/g wet weight.

Treatment:

Other: Medium nicotine

High nicotine

Active Comparator group

Description:

Conventional smokeless tobacco product with NNN plus NNK of \<2 μg/gram and nicotine levels of \<3 mg/g wet weight

Treatment:

Other: High nicotine