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Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction

Phase 2
18 Years
65 Years
Open (Enrolling)
Nicotine Dependence

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Trial Information

Comparing the Health Effects of Smokeless Tobacco, Cigarette Smoking, and New Tobacco Products Advertised as Safer Alternatives Part of Tobacco Exposure Reduction

Cigarette smokers (n=125) will be recruited from the local metropolitan area using multiple
media outlets. Subjects who are medically and psychologically healthy will be recruited for
the study. Cigarette smokers will be informed of the study over the telephone and asked to
answer a brief tobacco use history and medical screening questionnaire. If subjects pass
the initial screening for the study, they will be asked to attend an orientation meeting
(cigarette smokers will attend separate orientations) at the Tobacco Use Research Center
where the study will be explained in more detail, informed consent will be obtained and a
full screening evaluation will occur. This evaluation includes the completion of several
comprehensive tobacco use and social history forms and a complete physical and psychological

Subjects will be required to attend the clinic once during Week 1 and once during Week 2 of
the study in order to obtain baseline data. At the end of Week 2, cigarette smokers will
either be randomly assigned to: 1) quit tobacco use and will be offered the choice of using
nicotine gum or lozenge, depending on personal preference (n= 25) or they will be assigned
to switch to: 2) Camel Snus (n=50) or 3) Taboka (n=50) for 4 weeks. During the next four
weeks, subjects will be asked to attend weekly clinic visits during which time study data
will be collected. After the 4 weeks of study product use, subjects will be required to
taper off of the tobacco or nicotine product over the next two weeks and then cease all
tobacco use by week 9. Withdrawal symptoms will be assessed at Week 8, and for the first
week following cessation. Follow-up visits will be conducted 1 week (Week 9) and 12 weeks
(Week 19) after completion of the study and outcome measures will be taken at that time.
Blood and urine samples will be collected and analyzed for tobacco related toxicants.

Inclusion Criteria:

- Subjects between 18-65 years of age

- Smoking at least 15 cigarettes/day for at least one year

- Good physical and mental health as evidenced by a medical history with no unstable
medical conditions.

Exclusion Criteria:

- Uncontrolled chronic disease or condition that requires medical attention during the
course of the study

- Contraindications for nicotine replacement products: active ulcers, recent heart
attack, heart disease or irregular heart beat, uncontrolled high blood pressure, or
medication use that might affect tobacco use

- Current unstable psychiatric diagnoses or persons who currently are adjusting
medication dose. (within the last 3 months)

- Subjects with current or recent (within 6 months) alcohol or drug abuse problem

- Other regular tobacco use such as regular cigar or pipe smoking

- Currently using other nicotine replacement products

- Chronic use of any drug that could interact with the study drugs.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicant exposure by products

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Dorothy Hatsukami, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Minnesota - Clinical and Translational Science Institute


United States: Federal Government

Study ID:

P50 DA013333



Start Date:

January 2007

Completion Date:

February 2009

Related Keywords:

  • Nicotine Dependence
  • Biomarkers
  • Smoking
  • Tobacco
  • Cessation
  • Tobacco Use Disorder
  • Smoking



Tobacco Use Research Center Minneapolis, Minnesota  55414