Human Laboratory Study of Smokeless Tobacco Products

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.

Study Overview

• Status: Withdrawn
• Conditions: Smokeless Tobacco
• Intervention / Treatment: Other: Nicotine Lozenge; Other: Camel Snus Frost; Other: Stonewall Dissolvable Tobacco Pieces; Other: Skoal Wintergreen

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Tobacco Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nicotine Lozenge; 4 mg nicotine lozenge (LOZ	Other: Nicotine Lozenge; 4 mg for 12 days; Other Names: Commit Nicotine Lozenge
Active Comparator: Camel Snus Frost	Other: Camel Snus Frost; pouches, 6.2 mg nicotine, for 12 days; Other Names: Camel Snus Frost Pouches
Active Comparator: Stonewall Spearment Tablet	Other: Stonewall Dissolvable Tobacco Pieces; 5.6 mg nicotine pieces for 12 days; Other Names: Stonewall Spearmint Tablet
Active Comparator: Skoal Wintergreen	Other: Skoal Wintergreen; Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.; Other Names: Skoal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Marc Mooney, Ph.D., Dept. Psychiatry, University of Minnesota

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 6, 2010
• First Submitted That Met QC Criteria: April 7, 2010
• First Posted (Estimate): April 8, 2010

Study Record Updates

• Last Update Posted (Estimate): December 10, 2014
• Last Update Submitted That Met QC Criteria: December 9, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: nicotine; smokeless tobacco; chewing tobacco; snuff; snus; oral tobacco
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 2009NTLS097; 0911M74614 (Other Identifier: IRB, University of Minnesota)