Palatability of Experimental Cigarettes - Study 2

NCT01568905 | Completed Results

• 1 other identifier: 1012M94314
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

smoker; smoking; nicotine levels; tobacco; nicotine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Responses on Modified Cigarette Evaluation Scale

  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

  Baseline (Day 1) Compared to Second Visit (Week 1)

• Comparison of Number of Cigarettes Smoked

  1 week

Study Arms (3)

Arm 1 Low Level Nicotine Cigarette

EXPERIMENTAL

(0.4 mg/g)

Other: Low level nicotine cigarette

Arm 2 Intermediate Nicotine Level Cigarette

EXPERIMENTAL

(5.7-5.8 mg/g)

Other: Intermediate nicotine level cigarette

Arm 3 High Level Nicotine Cigarette

EXPERIMENTAL

(11.4-12.8 mg/g)

Other: High level nicotine cigarette

Interventions

Low level nicotine cigarette OTHER

smoke the study cigarette exclusively for one week

Arm 1 Low Level Nicotine Cigarette

Intermediate nicotine level cigarette OTHER

smoke the study cigarette exclusively for one week

Arm 2 Intermediate Nicotine Level Cigarette

High level nicotine cigarette OTHER

smoke the study cigarette exclusively for one week

Arm 3 High Level Nicotine Cigarette

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Regular smokers (10+ cigarettes per day and has done so for the last year)
• Inhaling when smoking
• Carbon monoxide (CO) \> 8 ppm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• 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.

  PMID: 23178320 RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dorohty Hatsukami, Ph.D.
• Organization: University of Minnesota Tobacco Research Programs

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, Ph.D.

  Tobacco Use Research Program, University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2012
• First Posted: April 2, 2012
• Study Start: February 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 1, 2019
• Results First Posted: January 12, 2017

Record last verified: 2019-10

Locations

US (1)