MedDataX Logo

Human Laboratory Study of Smokeless Tobacco Products

NCT ID: NCT01100216

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smokeless Tobacco

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

smokeless tobacco nicotine snus snuff chewing tobacco oral tobacco

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Nicotine Lozenge

4 mg nicotine lozenge (LOZ

Group Type ACTIVE_COMPARATOR

Nicotine Lozenge

Intervention Type OTHER

4 mg for 12 days

Camel Snus Frost

Group Type ACTIVE_COMPARATOR

Camel Snus Frost

Intervention Type OTHER

pouches, 6.2 mg nicotine, for 12 days

Stonewall Spearment Tablet

Group Type ACTIVE_COMPARATOR

Stonewall Dissolvable Tobacco Pieces

Intervention Type OTHER

5.6 mg nicotine pieces for 12 days

Skoal Wintergreen

Group Type ACTIVE_COMPARATOR

Skoal Wintergreen

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Nicotine Lozenge

4 mg for 12 days

Intervention Type OTHER

Stonewall Dissolvable Tobacco Pieces

5.6 mg nicotine pieces for 12 days

Intervention Type OTHER

Camel Snus Frost

pouches, 6.2 mg nicotine, for 12 days

Intervention Type OTHER

Skoal Wintergreen

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Commit Nicotine Lozenge Stonewall Spearmint Tablet Camel Snus Frost Pouches Skoal

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marc Mooney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Dept. Psychiatry, University of Minnesota

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Tobacco Research Center

Minneapolis, Minnesota, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0911M74614

Identifier Type: OTHER

Identifier Source: secondary_id

2009NTLS097

Identifier Type: -

Identifier Source: org_study_id