Palatability of Experimental Cigarettes - Study 2

University of Minnesota (UMN)

Status: Completed

Conditions: Smoking

Treatments: Other: Low level nicotine cigarette; Other: High level nicotine cigarette; Other: Intermediate nicotine level cigarette

Study type: Interventional

Funder types: Other

Identifiers

NCT01568905

1012M94314

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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36 participants in 3 patient groups

Arm 1 Low Level Nicotine Cigarette

Experimental group

Description:

(0.4 mg/g)

Treatment:

Other: Low level nicotine cigarette

Arm 2 Intermediate Nicotine Level Cigarette

Experimental group

Description:

(5.7-5.8 mg/g)

Treatment:

Other: Intermediate nicotine level cigarette

Arm 3 High Level Nicotine Cigarette

Experimental group

Description:

(11.4-12.8 mg/g)

Treatment:

Other: High level nicotine cigarette