Human Laboratory Study of Smokeless Tobacco Products

NCT01100216 | Withdrawn

• 2 other identifiers: 2009NTLS0970911M74614
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Smokeless Tobacco

Keywords

smokeless tobacco; nicotine; snus; snuff; chewing tobacco; oral tobacco

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Cognition Impairments

  Week 10

• Startle Response

  Week 10

• Reinforcement

  Week 10

Study Arms (4)

Nicotine Lozenge

ACTIVE COMPARATOR

4 mg nicotine lozenge (LOZ

Other: Nicotine Lozenge

Camel Snus Frost

ACTIVE COMPARATOR

Other: Camel Snus Frost

Stonewall Spearment Tablet

ACTIVE COMPARATOR

Other: Stonewall Dissolvable Tobacco Pieces

Skoal Wintergreen

ACTIVE COMPARATOR

Other: Skoal Wintergreen

Interventions

Nicotine Lozenge OTHER

4 mg for 12 days

Also known as: Commit Nicotine Lozenge

Nicotine Lozenge

Stonewall Dissolvable Tobacco Pieces OTHER

5.6 mg nicotine pieces for 12 days

Also known as: Stonewall Spearmint Tablet

Stonewall Spearment Tablet

Camel Snus Frost OTHER

pouches, 6.2 mg nicotine, for 12 days

Also known as: Camel Snus Frost Pouches

Camel Snus Frost

Skoal Wintergreen OTHER

Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.

Also known as: Skoal

Skoal Wintergreen

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Tobacco Research Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Marc Mooney, Ph.D.

  Dept. Psychiatry, University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2010
• First Posted: April 8, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

US (1)