Manipulating Tobacco Constituents in Male Menthol Smokers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Manipulating Tobacco Constituents in Male Menthol Smokers

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Other: Reduced Nicotine Non-Menthol (RNC)
* Other: Reduced Nicotine Menthol (RNC-Men)
* Other: Conventional Nicotine Non-Menthol (CN)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smoking at least 5 menthol cigarettes daily for the last year; able to speak, read and understand English; male age 18 -45 years of age; stable residence; not intending to quit smoking within the next 6 weeks. Exclusion Criteria: 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.); substance use which exceeds any of the following: marijuana use 3x/week, consuming 21 drinks/week or illicit drug use 1x/week; history of cardiovascular disease; current blood clot in arms or legs; blood pressure >160/100; 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 Serious quit attempts in the last 3 months; regular use (e.g., greater than weekly) of tobacco products other than cigarettes; currently using nicotine replacement or other tobacco cessation products

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Nicotine Non-Menthol (RNC)<br>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. | Other: Reduced Nicotine Non-Menthol (RNC)<br>* Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.<br>* Other names: SPECTRUM Research Cigarette - NRC 200;|
| Experimental: Reduced Nicotine Menthol (RNC-Men)<br>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. | Other: Reduced Nicotine Menthol (RNC-Men)<br>* Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.<br>* Other names: SPECTRUM Research Cigarette - NRC 201;|
| Experimental: Conventional Nicotine Non-Menthol (CN)<br>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. | Other: Conventional Nicotine Non-Menthol (CN)<br>* Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.<br>* Other names: SPECTRUM Research Cigarette - NRC 600;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender differences and change in number of investigational tobacco product(s) smoked per day as assessed by the Timeline Follow-Back (TLFB) | Data analyses will include subjects from this study matched to female subjects from the parent study. | Baseline, 6 weeks, and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gender differences and changes in craving as assessed by Minnesota Nicotine Withdrawal Scale (MNWS). |  | Baseline, 6 weeks, and 12 weeks | 
| Gender differences and changes in nicotine dependence as assessed by the Wisconsin Index of Smoking Dependence Motives (WISDM). |  | Baseline, 6 weeks, and 12 weeks | 
| Gender differences and changes in nicotine dependence as assessed by the Fagerstrom Test of Nicotine Dependence (FTND) |  | Baseline, 6 weeks, and 12 weeks | 
| Supertaster status as measured by genotyping for taster-receptor genes associated with taste behaviors. |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menthol, nicotine, reduced nicotine, smoking, cigarette, cigarettes, men smoking, smoking research, nicotine dependence