Palatability of Experimental Cigarettes - Study 2

Study Overview
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Brief Summary
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Smoking remains a leading cause of preventable disease and premature death worldwide. Approximately 1 out of every 5 deaths is associated with cigarette smoking, and roughly half of all daily smokers will die prematurely from tobacco-related illness. Reducing the nicotine in cigarettes to the point that they are rendered non-addictive can potentially be an effective public policy measure that can significantly reduce tobacco-related mortality and morbidity by decreasing the initiation of smoking and promoting cessation. The Family Smoking Prevention and Tobacco Control Act (FSPTCA) enables the FDA to establish tobacco product standards including placing limits on the allowable nicotine content of cigarettes. Currently, no reduced nicotine cigarettes are available that will allow studying the feasibility of this policy measure. The National Institute on Drug Abuse has contracted with Research Triangle Institute to assist in the development of cigarettes with varying nicotine content that can be made available to researchers. They have established a contract that will result in the manufacture of 9 million cigarettes to be distributed to the research community. Prior to full production, the palatability and nicotine intake of these cigarettes in smokers must be determined.

Detailed Description
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Phase 3: This descriptive study will use a between subjects, double blind design. This study will test 3 nicotine levels of nicotine, tar and ventilation. Subjects and research assistants will be blind to the cigarette type.

Official Title
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Palatability of Experimental Cigarettes

Conditions
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Smoking

Intervention / Treatment
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* Other: Low level nicotine cigarette
* Other: Intermediate nicotine level cigarette
* Other: High level nicotine cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-64 years old Regular smokers (10+ cigarettes per day and has done so for the last year) Inhaling when smoking Carbon monoxide (CO) > 8 ppm Exclusion Criteria: In the past year, suffered from any cardiovascular disease such as: heart disease, heart attack, stroke or angina, any respiratory diseases such as chronic bronchitis or chronic obstructive pulmonary disease (COPD), any type of cancer Currently suffering from Bipolar Disorder, General Anxiety Disorder, Schizophrenia, or a major depressive episode Taken any of the following drugs more than twice per week during the past month: antidepressants, anti-anxiety medications. Consumed more than 15 alcoholic drinks per week for the past month Pregnant, trying to become pregnant, or lactating (assessed by self-report) In the past 3 months, used nicotine replacement products (like the patch, gum, or inhaler), or the medications bupropion varenicline Currently trying or planning to reduce or quit tobacco use in the next 30 days Used other forms of tobacco 10 or more days in the past 30 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

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: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 Low Level Nicotine Cigarette<br>(0.4 mg/g) | Other: Low level nicotine cigarette<br>* smoke the study cigarette exclusively for one week<br>|
| Experimental: Arm 2 Intermediate Nicotine Level Cigarette<br>(5.7-5.8 mg/g) | Other: Intermediate nicotine level cigarette<br>* smoke the study cigarette exclusively for one week<br>|
| Experimental: Arm 3 High Level Nicotine Cigarette<br>(11.4-12.8 mg/g) | Other: High level nicotine cigarette<br>* smoke the study cigarette exclusively for one week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 | Two urine TNE levels are taken, one at baseline and one at week 1, to assess TNE levels for nicotine exposure. TNE is the sum of nicotine, cotinine, trans 3'-hydroxycotinine and their respective glucuronide conjugates. Values reported in nmols/ml. | Second Visit (Week 1) minus Baseline (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responses on Modified Cigarette Evaluation Scale | Modified Cigarette Evaluation Scale [CES] is a 100 mm visual analog scale (0=not at all or very little nicotine; 100=extremely or high in nicotine) of 20 questions assessing different dimensions of responses to usual brand cigarettes (e.g., psychological reward, satisfaction and aversiveness) and includes additional 5 point likert-type questions (definitely agree to definitely disagree) on perceptions of satisfaction and willingness to use the product. Results satisfaction subscale. | Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1) | 
| Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes | Questionnaire: Perceived Health Risk Scale asks subjects to rate their perception of health risks for lung cancer for the study product to which they have been randomly assigned. This is a 100 mm visual analog scale; 0=very low risk of disease, 100=very high risk of disease. | Baseline (Day 1) Compared to Second Visit (Week 1) | 
| Comparison of Number of Cigarettes Smoked | Subjects were given a daily diary to collect the number of study and/or conventional cigarettes they have smoked each day. Cigarettes smoked (both usual brand and experimental) in a given week were summed over the first 7 reported days. If the number of cigarettes smoked was missing for 1 day, the average of the other days in that week was used in its place and reported as total number of cigarettes per week. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoker, smoking, nicotine levels, tobacco, nicotine