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Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction


Phase 3
18 Years
N/A
Not Enrolling
Both
Smokeless Tobacco Use

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Trial Information

Evaluating Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction


Smokeless tobacco (ST) users will be randomly assigned to either the 4-mg active nicotine
lozenge or matching placebo. Both groups will receive a behavioral intervention. The two
sites for this clinical trial will be the Mayo Clinic in Rochester, Minnesota (central
coordinating site) and the Oregon Research Institute (ORI) in Eugene, OR. A total of 270 ST
users will be recruited into this clinical trail. All subjects will be randomized to 4 mg
Nicotine Lozenges (taken ad lib) or matching placebo. They will be on study medication for
12 weeks and followed up for 6 months from study enrollment


Inclusion Criteria:



- are at least 18 years of age;

- report smokeless tobacco (ST) as their primary tobacco of use;

- have used ST daily for the past 6 months;

- are in general good health (determined by medical history and screening physical
examination);

- have been provided with, understand, and have signed the informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Prolonged Smokeless Tobacco Abstinence at 3 Months

Outcome Description:

Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.

Outcome Time Frame:

3 months

Safety Issue:

No

Principal Investigator

Jon O. Ebbert, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Institutional Review Board

Study ID:

06-003091

NCT ID:

NCT00392379

Start Date:

January 2007

Completion Date:

March 2009

Related Keywords:

  • Smokeless Tobacco Use
  • Tobacco use disorder
  • Tobacco cessation

Name

Location
Mayo Clinic Rochester, Minnesota  55905
Oregon Research Institute Eugene, Oregon  97403