Manipulating Tobacco Constituents in Female 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 women of reproductive age, a vulnerable population identified by the FDA in need of further research.

Detailed Description
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Study is designed to address the following questions that have been outlined by the FDA as particular areas of interest: What are the factors, including menthol and other flavorings that influence the appeal of tobacco products to vulnerable populations: What is the impact of these factors on cessation, switching tobacco products and multiple use? What is the potential impact of modifying nicotine levels on dependence, and smoking rate and cessation, as well as patterns of switching products and use of multiple tobacco products? Beyond nicotine, what other constituents enhance addictive properties?

Official Title
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Manipulating Tobacco Constituents in Female Menthol Smokers

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Other: Reduced Nicotine Content- Non Menthol
* Other: Reduced Nicotine Content- Menthol
* Other: Conventional Nicotine Content- Menthol
* Other: Conventional Nicotine Content- Non Menthol


Participation Criteria
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Eligibility Criteria
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Inclusion criteria are: smoking at least 5 menthol cigarettes daily for the last year; able to speak, read and understand English female age 18 -45 years of age; stable residence; not intending to quit smoking within the next 6 weeks. Exclusion criteria are: unstable psychiatric disorder (Psychiatric symptoms reported by patient or identified in medical record 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 (based on history and drug and alcohol questionaires) or other heart conditions. The study physician will determine whether a given medical condition is unstable and the appropriateness of study participation for a particular subject; Serious quit attempts in the last 3 months (to ensure stability of smoking); regular use (e.g., greater than weekly) of tobacco products other than cigarettes; Currently using nicotine replacement or other tobacco cessation products (to minimize confounding effects of another product); Pregnant or breastfeeding those planning to become pregnant,and those who are of childbearing potential and are not using an acceptable form of birthcontrol such as Depo-provera, Norplant, tubal ligation and barrier methods such as condoms or diaphragm.

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

Sexes Eligible for Study
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Female

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: Basic Science
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Reduced Nicotine Content -Non Menthol<br>Switch from own brand of cigarette to SPECTRUM research cigarettes (NRC 200-Reduced Nicotine Content cigarette) which contain 0.07mg nicotine yield without menthol. | Other: Reduced Nicotine Content- Non Menthol<br>* Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.<br>* Other names: SPECTRUM Research Cigarette - NRC 200;|
| Experimental: Reduced Nicotine Content- Menthol<br>Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol | Other: Reduced Nicotine Content- Menthol<br>* Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol<br>* Other names: SPECTRUM Research Cigarette - RNC 201;|
| Active Comparator: Conventional Nicotine Content- Menthol<br>Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used. | Other: Conventional Nicotine Content- Menthol<br>* Allow own brand of Conventional Nicotine-Menthol Cigarette<br>* Other names: Own brand of Conventional Nicotine-Menthol Cigarette;|
| Experimental: Conventional Nicotine Content- Non Menthol<br>Switch from own brand of cigarette to SPECTRUM research cigarette (NRC-600 Conventional Nicotine )which contains conventional nicotine yield. | Other: Conventional Nicotine Content- Non Menthol<br>* Switch from own cigarette to a research cigarette 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 |
| --- | --- | --- |
| The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence. | Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicant Exposure | Examine the effects of reduced nicotine and menthol removal on toxicant exposure for the outcomes-- cotinine, exhaled carbon monoxide, and urine carcinogens and other tobacco specific nitrosamines. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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menthol, nicotine