Human Laboratory Study of Smokeless Tobacco Products

University of Minnesota (UMN)

Status

Withdrawn

Conditions

Smokeless Tobacco

Treatments

Other: Camel Snus Frost

Other: Skoal Wintergreen

Other: Nicotine Lozenge

Other: Stonewall Dissolvable Tobacco Pieces

Study type

Interventional

Funder types

Other

Identifiers

NCT01100216

0911M74614 (Other Identifier)

2009NTLS097

Details and patient eligibility

About

With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.

Full description

Treatment will be a 3-period crossover study using Commit Nicotine Lozenge, Stonewall Disposable Tobacco Pieces and Camel Snus Frost Pouches. Each period will last 14 days with 11 days of product use and 1.5 days abstinence of all nicotine-containing products for a total of 10 weeks. Participants will begin the study by completing a baseline assessment on their own product, Skoal Wintergreen.

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects will be 20 male smokeless tobacco (SLT) users who are not seeking to quit (less than 5% of females use SLT.
Subjects will be Skoal Wintergreen SLT users, since this is the most commonly used SLT that uses a mint-type flavorant.
Subjects will have used SLT for at least 1 year..
Subjects will be English speaking and reading.
Provide written informed consent.

Exclusion criteria

Subjects who have used other tobacco products (i.e., cigarettes, cigars) or nicotine products in past 6 months.
Subjects who take medications that might affect the outcome of laboratory measures.
Subjects with a history of major mood, thought, anxiety or attentional disorders.