Human Laboratory Study of Smokeless Tobacco Products

Smokeless Tobacco Clinical Trial

Official title:

Human Laboratory Study of Smokeless Tobacco Products

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01100216
• Other study ID #: 2009NTLS097
• Secondary ID: 0911M74614
• Status: Withdrawn
• Phase: N/A
• First received: April 6, 2010
• Last updated: December 9, 2014
• Start date: March 2010
• Est. completion date: December 2010

Study information

• Verified date: December 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smokeless Tobacco

Intervention

Other:
• Nicotine Lozenge
4 mg for 12 days
• Stonewall Dissolvable Tobacco Pieces
5.6 mg nicotine pieces for 12 days
• Camel Snus Frost
pouches, 6.2 mg nicotine, for 12 days
• Skoal Wintergreen
Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.

Locations

Country	Name	City	State
United States	Tobacco Research Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Week 10	No
Secondary	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).	Week 10	No
Secondary	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).	Week 10	No
Secondary	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).	Week 10	No