Manipulating Tobacco Constituents in Female Menthol Smokers (Menthol)
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|ClinicalTrials.gov Identifier: NCT02048852|
Recruitment Status : Suspended (COVID-19 pandemic)
First Posted : January 29, 2014
Last Update Posted : April 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Other: Reduced Nicotine Content- Non Menthol Other: Reduced Nicotine Content- Menthol Other: Conventional Nicotine Content- Menthol Other: Conventional Nicotine Content- Non Menthol||Not Applicable|
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?
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||320 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Manipulating Tobacco Constituents in Female Menthol Smokers|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Reduced Nicotine Content -Non Menthol
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
Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
Other Name: SPECTRUM Research Cigarette - NRC 200
Experimental: Reduced Nicotine Content- Menthol
Switch from own brand of cigarette to Reduced Nicotine Research Cigarettes which contain 0.07mg nicotine yield with Menthol
Other: Reduced Nicotine Content- Menthol
Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
Other Name: SPECTRUM Research Cigarette - RNC 201
Active Comparator: Conventional Nicotine Content- Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette. No research cigarettes used.
Other: Conventional Nicotine Content- Menthol
Allow own brand of Conventional Nicotine-Menthol Cigarette
Other Name: Own brand of Conventional Nicotine-Menthol Cigarette
Experimental: Conventional Nicotine Content- Non Menthol
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
Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
Other Name: SPECTRUM Research Cigarette - NRC 600
- The goal of the cigarette conditions is to find the impact of varying nicotine and menthol concentrations on smoking rate and abstinence. [ Time Frame: 12 weeks ]Alter the nicotine and menthol concentrations of cigarettes administered to subjects as randomized.
- Toxicant Exposure [ Time Frame: 12 weeks ]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.
- Cigarette content manipulations effect on a model mediating usage [ Time Frame: 12 Weeks ]Examine cigarette content manipulation (nicotine reduction and menthol removal) as independent variables and the number of cigarettes recorded daily as dependent variable..Measures that will be tested for include subscales of the cigarette evaluations as well as craving, affect and mood, and self-confidence
- Effect of taster status [ Time Frame: 12 Weeks ]To explore the moderating effects of supertasters with menthol assignments to predict compliance with treatment, cigarette taste and aversion. A logistic model will be used to predict post-treatment abstinence. The interaction between supertaster and menthol will test for the moderating effect.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02048852
|United States, Connecticut|
|UCONN Health Center|
|Farmington, Connecticut, United States, 06030|
|Hartford, Connecticut, United States, 06102|
|Principal Investigator:||Cheryl A Oncken, MD MPH||UCONN Health Center|