Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine - Full Text View

Purpose

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	Intervention	Phase
Tobacco Toxicant Exposure	Drug: Deuterated phenanthrene	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine

Resource links provided by NLM:

MedlinePlus related topics: Cancer Smoking Urine and Urination

U.S. FDA Resources

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

Primary Outcome Measures:

Pharmacokinetics [ Time Frame: 36 hours post dosing ] [ Designated as safety issue: No ]
Deuterated phenanthrene tetraol ([D10]PheT) assessed post dosing for smoked versus oral administration.

Estimated Enrollment:	30
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01092650

Contacts

Contact: Stephen S Hecht, Ph.D.	612-624-7604	hecht002@umn.edu
Contact: Joni Jensen, MPH	612-627-5178	jense010@umn.edu

Locations

United States, Minnesota
Tobacco Use Research Center	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Joni A Jensen, MPH 612-624-5178 jense010@umn.edu
Contact: Stephen S Hecht, Ph.D. 612-624-7604 hecht002@umn.edu
Principal Investigator: Stephen S Hecht, Ph.D.

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

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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
Study First Received:	March 23, 2010
Last Updated:	February 20, 2013
Health Authority:	United States: Food and Drug Administration

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

Tobacco toxicants
Polycyclic aromatic hydrocarbons
Smoking

ClinicalTrials.gov processed this record on May 16, 2013