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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01092650
First Posted: March 25, 2010
Last Update Posted: October 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine

Resource links provided by NLM:


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

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


Estimated Enrollment: 30
Study Start Date: September 2007
Study Completion Date: December 2011
Primary Completion Date: December 2011 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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:
ATSDR (Agency for Toxic Substances and Disease Registry). 1990. Toxicological Profile for Polycyclic Aromatic Hydrocarbons. Acenaphthene, Acenaphthylene, Anthracene, Benzo(a)anthracene, Benzo(a)pyrene, Benzo(b)fluoranthene, Benzo(g,i,h)perylene, Benzo(k)fluoranthene, Chrysene, Dibenzo(a,h)anthracene, Fluoranthene, Fluorene, Indeno(1,2,3-c,d)pyrene, Phenanthrene, Pyrene. Prepared by Clement International Corporation, under Contract No. 205-88-0608. ATSDR/TP-90-20.
Bock, F.G. and T.L. Dao. 1961. Factors affecting the polynuclear hydrocarbon level in rat mammary glands. Cancer Res. 21: 1024-1029.
Budavari, S., M.J. O'Neil and A. Smith (Eds.). 1989. The Merck Index. Merck & Co., Inc. Rahway, NJ, pp. 1143-1144.
Chang, L.H. 1943. The fecal excretion of polycyclic hydrocarbons following their administration to the rat. J.. biol. Chem. 151: 93-99.
IARC (International Agency for Research and Cancer). 1983. IARC Monographs on the Evaluation of Carcinogenic Risks to Humans. Polynuclear Aromatic Compounds. Part 1. Chemical Environmental and Experimental Data, Vol. 32. World Health Organization, Lyon, France, pp. 419-430.
Kennaway, E.L. 1924. On the cancer-producing tars and tar-fractions. J. Ind. Hyg. 5: 462-488.
Mabey, W.R., J.H. Smith, R.T. Podoll, et al. 1982. Aquatic fate process data for organic priority pollutants. U.S. Environmental Protection Agency, Office of Water Regulations and Standards, Washington, D.C. EPA 440/4-81-014.
Pfeiffer, E.H. 1977. Oncogenic interaction of carcinogenic and non-carcinogenic polycyclic aromatic hydrocarbons in mice. IARC Scientific Publication No. 16. Air Pollution and Cancer in Man. International Agency for Research on Cancer, Lyon, France, pp. 69-77. (Cited in ATSDR, 1990)
Roe, F.J.C. and G.A. Grant. 1964. Tests of pyrene and phenanthrene for incomplete carcinogenic and anticarcinogenic activity. Br. Emp. Cancer Campaign 41: 59-60. (Abstract) (Cited in IARC, 1983)
Salamone, M.F. 1981. Toxicity of 41 carcinogenic analogs. Prog. Mutat. Res. 1: 682-685. (Cited in U.S. EPA, 1988)
Sax, N.I. and R.L. Lewis (Eds.). 1987. Hawley's Condensed Chemical Dictionary, 11th ed. Van Nostrand Reinhold Company, New York, p. 895.
U.S. EPA (U.S. Environmental Protection Agency). 1987. Health and Environmental Effects Profile for Phenanthrene. Prepared by the Environmental Criteria and Assessment Office, Office of Health

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01092650     History of Changes
Other Study ID Numbers: 0707M13481
First Submitted: March 23, 2010
First Posted: March 25, 2010
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