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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01092650
First received: March 23, 2010
Last updated: February 20, 2013
Last verified: February 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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.
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.

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 August 21, 2014