Clinical trial NCT01568905: Palatability of Experimental Cigarettes - Study 2
Official title: Palatability of Experimental Cigarettes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoker
smoking
nicotine levels
tobacco
nicotine
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1
timeFrame: Second Visit (Week 1) minus Baseline (Day 1)
Secondary outcomes:
measure: Responses on Modified Cigarette Evaluation Scale
timeFrame: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1)
measure: Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes
timeFrame: Baseline (Day 1) Compared to Second Visit (Week 1)
measure: Comparison of Number of Cigarettes Smoked
timeFrame: 1 week
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: Tobacco Use Research Program, University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hatsukami DK, Heishman SJ, Vogel RI, Denlinger RL, Roper-Batker AN, Mackowick KM, Jensen J, Murphy SE, Thomas BF, Donny E. Dose-response effects of spectrum research cigarettes. Nicotine Tob Res. 2013 Jun;15(6):1113-21. doi: 10.1093/ntr/nts247. Epub 2012 Nov 22.