Manipulating Tobacco Constituents in Male Menthol Smokers

UConn Health

Status: Completed

Conditions: Nicotine Dependence

Treatments: Other: Conventional Nicotine Non-Menthol (CN); Other: Reduced Nicotine Menthol (RNC-Men); Other: Reduced Nicotine Non-Menthol (RNC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02592772

HHC-2015-0128

3R01DA036486-02S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 118 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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 protocol
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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 3 patient groups

Reduced Nicotine Non-Menthol (RNC)

Experimental group

Description:

Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine non menthol cigarettes (RNC: NRC 200; 0.07 mg nicotine yield cigarettes without menthol) during the 6 week experimental phase.

Treatment:

Other: Reduced Nicotine Non-Menthol (RNC)

Reduced Nicotine Menthol (RNC-Men)

Experimental group

Description:

Study participants will be randomized from their own brand of menthol cigarettes to the reduced nicotine menthol cigarettes (RNC-Men: NRC 201; 0.07 mg reduced nicotine content menthol cigarettes) during the 6 week experimental phase.

Treatment:

Other: Reduced Nicotine Menthol (RNC-Men)

Conventional Nicotine Non-Menthol (CN)

Experimental group

Description:

Study participants will be randomized from their own brand of menthol cigarettes to the regular/conventional nicotine non menthol cigarettes (CN: NRC 600; 0.8 mg nicotine content) during the 6 week experimental phase.

Treatment:

Other: Conventional Nicotine Non-Menthol (CN)