Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine

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ClinicalTrials.gov Identifier: NCT01092650

Recruitment Status : Completed

First Posted : March 25, 2010

Last Update Posted : October 27, 2014

Sponsor:

Information provided by (Responsible Party):

University of Minnesota - Clinical and Translational Science Institute

Study Description

Brief Summary:

The purpose of this research study is to better understand how people respond to cancer-causing chemicals in cigarette smoke. Some people are able to get rid of these chemicals as harmless agents while others suffer damage to their cells that can ultimately result in cancer. We hope to develop a better understanding of how we can identify the people who are in danger of getting cancer. Participants will complete questionnaires regarding their health and smoking history. We will take blood samples to look at genes which determine how the body breaks down some tobacco-related toxins. Participants will be given a small amount of liquid to drink, containing alcohol, water, and a compound called deuterated phenanthrene (DP), which is found in cigarette smoke and in the environment. Phenanthrene is non-toxic and does not cause cancer, but this compound is broken down by the body in the same way as cancer-causing agents. We will follow the pathway of this compound as it is broken down in the body.

Condition or disease	Intervention/treatment	Phase
Tobacco Toxicant Exposure	Drug: Deuterated phenanthrene	Phase 1

Detailed Description:

Forty apparently healthy smokers and non smokers (20 male, 20 female) will be recruited by advertising in the Twin Cities area. This will be done by the Tobacco Use Research Center. They will be screened in a phone call, then invited to come in for an orientation session at which consent will be obtained. Pregnant smokers will be excluded. They will visit the clinic weekly for 2 months and once monthly for 4 months for a total of 6 months participation.

At each visit they will drink 5 ml of 50:50 ethanol:water containing 10 ug [D10]phenanthrene. They will then collect their 24h urine and return it to the clinic. The urine will be analyzed for [D10]phenanthrene tetraol. The goal of the study is to determine the longitudinal stability of the amount of [D10]phenanthrene-tetraol in urine.

Study Design


Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	30 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Primary Purpose:	Basic Science
Official Title:	Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
Study Start Date :	September 2007
Actual Primary Completion Date :	December 2011
Actual Study Completion Date :	December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Smoked Deuterated Phenanthrene spiked in a study cigarette	Drug: Deuterated phenanthrene Deuterated phenanthrene 10 micrograms
Experimental: Oral Deuterated phenanthrene in an oral dose	Drug: Deuterated phenanthrene Deuterated phenanthrene 10 micrograms

Outcome Measures

Primary Outcome Measures :

Pharmacokinetics [ Time Frame: 36 hours post dosing ]
Deuterated phenanthrene tetraol ([D10]PheT) assessed post dosing for smoked versus oral administration.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

smokers and non-smokers
smoking at least 10 cigarettes daily for the past year (for smokers)
in good physical health (no unstable medical condition)
stable, good mental health (not currently, within past 6 months, experiencing unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion Criteria:

subjects who have, within the past 6 months, experienced unstable or untreated psychiatric diagnoses, including substance abuse, as determined by the DSM-IV criteria.
subjects using any other tobacco or nicotine products.
female subjects who are pregnant or nursing.
subjects with an unstable medical condition.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01092650

Locations


United States, Minnesota
Tobacco Use Research Center
Minneapolis, Minnesota, United States, 55455

Sponsors and Collaborators

University of Minnesota - Clinical and Translational Science Institute

Investigators


Principal Investigator:	Stephen S Hecht, Ph.D.	University of Minnesota Masonic Cancer Center

More Information

Publications:

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Responsible Party:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT01092650 History of Changes
Other Study ID Numbers:	0707M13481
First Posted:	March 25, 2010 Key Record Dates
Last Update Posted:	October 27, 2014
Last Verified:	October 2014

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:


Tobacco toxicants Polycyclic aromatic hydrocarbons Smoking

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