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Palatability of Experimental Cigarettes


N/A
18 Years
64 Years
Open (Enrolling)
Both
Smoking

Thank you

Trial Information

Palatability of Experimental Cigarettes


Phase 3: This descriptive study will use a between subjects, double blind design. This study
will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research
assistants will be blind to the cigarette type.


Inclusion Criteria:



- 18-64 years old

- Regular smokers (10+ cigarettes per day and has done so for the last year)

- Inhaling when smoking

- Carbon monoxide (CO) > 8 ppm

Exclusion Criteria:

- In the past year, suffered from any cardiovascular disease such as: heart disease,
heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis
or chronic obstructive pulmonary disease (COPD), any type of cancer

- Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia,
or a major depressive episode

- Taken any of the following drugs more than twice per week during the past month:
antidepressants, anti-anxiety medications.

- Consumed more than 15 alcoholic drinks per week for the past month

- Pregnant, trying to become pregnant, or lactating (assessed by self-report)

- In the past 3 months, used nicotine replacement products (like the patch, gum, or
inhaler), or the medications bupropion varenicline

- Currently trying or planning to reduce or quit tobacco use in the next 30 days

- Used other forms of tobacco 10 or more days in the past 30 days

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Comparison of Urine Cotinine Levels and Total Nicotine Equivalent (TNE)

Outcome Description:

Two urine cotinine levels are taken, one at baseline and one at week 1, to assess cotinine levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucouronide conjugates.

Outcome Time Frame:

Baseline (Day 1) Compared to Week 1

Safety Issue:

No

Principal Investigator

Dorothy Hatsukami, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tobacco Use Research Program, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2011NTLS004

NCT ID:

NCT01568905

Start Date:

February 2011

Completion Date:

March 2013

Related Keywords:

  • Smoking
  • smoker
  • smoking
  • nicotine levels
  • tobacco
  • nicotine
  • Smoking

Name

Location
University of Minnesota Minneapolis, Minnesota  55455