Human Laboratory Study of Smokeless Tobacco Products
- Conditions
- Smokeless Tobacco
- Interventions
- Other: Camel Snus FrostOther: Stonewall Dissolvable Tobacco PiecesOther: Nicotine LozengeOther: Skoal Wintergreen
- Registration Number
- NCT01100216
- Lead Sponsor
- University of Minnesota
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Male
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Camel Snus Frost Camel Snus Frost - Stonewall Spearment Tablet Stonewall Dissolvable Tobacco Pieces - Nicotine Lozenge Nicotine Lozenge 4 mg nicotine lozenge (LOZ Skoal Wintergreen Skoal Wintergreen -
- Primary Outcome Measures
Name Time Method Withdrawal Severity Week 10 Comparing withdrawal symptoms between the different products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
- Secondary Outcome Measures
Name Time Method Reinforcement Week 10 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).
Cognition Impairments Week 10 Comparing differences between the smokeless tobacco products - 4 mg nicotine lozenge (LOZ), Camel Snus Frost (SNUS), Stonewall Spearmint Tablet (STAB), and Skoal Wintergreen (SKOL).
Startle Response Week 10 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).
Trial Locations
- Locations (1)
Tobacco Research Center
🇺🇸Minneapolis, Minnesota, United States