Manipulating Tobacco Constituents in Male Menthol Smokers

Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Age Range:18 - 45
Start Date:December 2015
End Date:March 2020
Contact:Sheila Thurlow
Phone:(860) 679-1751

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This study examines the potential effect of reducing nicotine content or menthol or both in
men. It will also examine whether there are gender differences in manipulating tobacco
flavors and nicotine concentrations in cigarettes on smoking behavior.

The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes.
The Tobacco Products Scientific Advisory Committee has noted, among other things, that
removal of menthol cigarettes from the marketplace would benefit the public health. A parent
study (NCT02048852) examines the potential impact of these two regulatory actions alone and
in combination in female menthol smokers. This supplemental study will recruit an additional
group of male menthol smokers, which will examine whether there are gender differences in
manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The
approach to add the opposite sex allows findings of sex/gender to be incorporated in the
design and development of new technologies (i.e., modified cigarettes). Emerging research
shows that women may be more responsive to the non-nicotine sensory aspects of smoking such
as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this
study expects to observe gender differences in response to manipulating flavors and nicotine
content in cigarettes.

Inclusion Criteria:

1. smoking at least 5 menthol cigarettes daily for the last year;

2. able to speak, read and understand English;

3. male age 18 -45 years of age;

4. stable residence;

5. not intending to quit smoking within the next 6 weeks.

Exclusion Criteria:

1. unstable psychiatric disorder (Psychiatric symptoms reported that cause current
significant impairment in functioning or judgment such that the person's ability to
come consistently for study appointments or render a decision regarding informed
consent is in question.);

2. substance use which exceeds any of the following: marijuana use 3x/week, consuming 21
drinks/week or illicit drug use 1x/week;

3. history of cardiovascular disease;

4. current blood clot in arms or legs;

5. blood pressure >160/100;

6. unstable medical problems which may include but are not limited to immune system
disorders, severe respiratory diseases, kidney or liver diseases, thyroid problems,
substance abuse or dependence that would limit patients ability to follow experimental

7. Serious quit attempts in the last 3 months;

8. regular use (e.g., greater than weekly) of tobacco products other than cigarettes;

9. currently using nicotine replacement or other tobacco cessation products
We found this trial at
Farmington, Connecticut 06030
Principal Investigator: Cheryl A. Oncken, MD MPH
Phone: 860-679-4637
Farmington, CT
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Phone: 860-972-2399
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
Hartford, CT
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