Palatability of Experimental Cigarettes - Study 2

Palatability of Experimental Cigarettes

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Low level nicotine cigarette; Other: Intermediate nicotine level cigarette; Other: High level nicotine cigarette

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.

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Dorothy Hatsukami, Ph.D., Tobacco Use Research Program, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: January 3, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Actual): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: smoking; tobacco; nicotine; smoker; nicotine levels
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: 1012M94314