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Human Laboratory Study of Smokeless Tobacco Products


N/A
18 Years
60 Years
Not Enrolling
Male
Smokeless Tobacco

Thank you

Trial Information

Human Laboratory Study of Smokeless Tobacco Products


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Withdrawal Severity

Outcome Description:

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

Outcome Time Frame:

Week 10

Safety Issue:

No

Principal Investigator

Marc Mooney, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dept. Psychiatry, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2009NTLS097

NCT ID:

NCT01100216

Start Date:

March 2010

Completion Date:

December 2010

Related Keywords:

  • Smokeless Tobacco
  • smokeless tobacco
  • nicotine
  • snus
  • snuff
  • chewing tobacco
  • oral tobacco

Name

Location
Tobacco Research Center Minneapolis, Minnesota  55455