Human Laboratory Study of Smokeless Tobacco Products

This study has been withdrawn prior to enrollment.
(Funding expired prior to implementing subject recruitment.)
Sponsor:
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01100216
First received: April 6, 2010
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Smokeless Tobacco
Other: Nicotine Lozenge
Other: Stonewall Dissolvable Tobacco Pieces
Other: Camel Snus Frost
Other: Skoal Wintergreen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Human Laboratory Study of Smokeless Tobacco Products

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Withdrawal Severity [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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:
  • Cognition Impairments [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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).

  • Reinforcement [ Time Frame: Week 10 ] [ Designated as safety issue: No ]
    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).


Enrollment: 0
Study Start Date: March 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Nicotine Lozenge
4 mg nicotine lozenge (LOZ
Other: Nicotine Lozenge
4 mg for 12 days
Other Name: Commit Nicotine Lozenge
Active Comparator: Camel Snus Frost Other: Camel Snus Frost
pouches, 6.2 mg nicotine, for 12 days
Other Name: Camel Snus Frost Pouches
Active Comparator: Stonewall Spearment Tablet Other: Stonewall Dissolvable Tobacco Pieces
5.6 mg nicotine pieces for 12 days
Other Name: 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 Name: Skoal

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01100216

Locations
United States, Minnesota
Tobacco Research Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Marc Mooney, Ph.D. Dept. Psychiatry, University of Minnesota
  More Information

No publications provided

Responsible Party: Marc Mooney, Ph.D., Dept. Psychiatry, University of Minnesota
ClinicalTrials.gov Identifier: NCT01100216     History of Changes
Other Study ID Numbers: 2009NTLS097, 0911M74614
Study First Received: April 6, 2010
Last Updated: August 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
smokeless tobacco
nicotine
snus
snuff
chewing tobacco
oral tobacco

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014