Human Laboratory Study of Smokeless Tobacco Products

University of Minnesota

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Conditions

Smokeless Tobacco

Interventions

Nicotine LozengeOTHER

4 mg for 12 days

Stonewall Dissolvable Tobacco PiecesOTHER

5.6 mg nicotine pieces for 12 days

Camel Snus FrostOTHER

pouches, 6.2 mg nicotine, for 12 days

Eligibility

Sex: MALEMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Tobacco Research Center

Minneapolis, Minnesota, United States

Outcomes

Primary Outcomes

Withdrawal Severity

Comparing withdrawal symptoms between the different products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).

Time frame: Week 10

Secondary Outcomes

Cognition Impairments

Comparing differences between the smokeless tobacco products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).

Time frame: Week 10

Startle Response

Negative emotional responses to nicotine-relevant stimulant (based on physiologoical and electrophysiological measures, and self-reports of affective valence, arousal and control/dominance) differences between products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).

Time frame: Week 10

Reinforcement

The break point (response workload at which subjects do not respond sufficiently to obtain a dosage of product in a defined time period) is expected to differ significantly between products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).

Time frame: Week 10

Data from ClinicalTrials.gov

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