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Palatability of Experimental Cigarettes - Study 2

NCT01568905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-11-01

Study results available
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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

Interventions

OTHER

Low level nicotine cigarette

smoke the study cigarette exclusively for one week

OTHER

Intermediate nicotine level cigarette

smoke the study cigarette exclusively for one week

OTHER

High level nicotine cigarette

smoke the study cigarette exclusively for one week

Sponsors & Collaborators

Principal Investigators

  • Dorothy Hatsukami, Ph.D. · Tobacco Use Research Program, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568905 on ClinicalTrials.gov