This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Palatability of Experimental Cigarettes - Study 2

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01568905
First received: January 3, 2012
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Smoking Other: Low level nicotine cigarette Other: Intermediate nicotine level cigarette Other: High level nicotine cigarette

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Palatability of Experimental Cigarettes

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Change in UrineTotal Nicotine Equivalent (TNE) Between Baseline and Week 1 [ Time Frame: Second Visit (Week 1) minus Baseline (Day 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.


Secondary Outcome Measures:
  • Responses on Modified Cigarette Evaluation Scale [ Time Frame: Baseline usual brand cigarettes (Day 1) compared to when using study cigarettes (Week 1) ]
    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.

  • Change From Baseline of Perceived Health Risk Scale Response to Test Cigarettes [ Time Frame: Baseline (Day 1) Compared to Second Visit (Week 1) ]
    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.

  • Comparison of Number of Cigarettes Smoked [ Time Frame: 1 week ]
    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.


Enrollment: 36
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568905

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Dorothy Hatsukami, Ph.D. Tobacco Use Research Program, University of Minnesota
  More Information

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01568905     History of Changes
Other Study ID Numbers: 248
Study First Received: January 3, 2012
Results First Received: December 2, 2015
Last Updated: January 17, 2017

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
smoker
smoking
nicotine levels
tobacco
nicotine

Additional relevant MeSH terms:
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 22, 2017