NCT01092650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

October 27, 2014

Status Verified

October 1, 2014

Enrollment Period

4.3 years

First QC Date

March 23, 2010

Last Update Submit

October 24, 2014

Conditions

Tobacco Toxicant Exposure

Keywords

Tobacco toxicantsPolycyclic aromatic hydrocarbonsSmoking

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    Deuterated phenanthrene tetraol (\[D10\]PheT) assessed post dosing for smoked versus oral administration.

    36 hours post dosing

Study Arms (2)

Smoked

ACTIVE COMPARATOR

Deuterated Phenanthrene spiked in a study cigarette

Drug: Deuterated phenanthrene

Oral

EXPERIMENTAL

Deuterated phenanthrene in an oral dose

Drug: Deuterated phenanthrene

Interventions

Deuterated phenanthreneDRUG

Deuterated phenanthrene 10 micrograms

OralSmoked

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tobacco Use Research Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (31)

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    BACKGROUND

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    BACKGROUND

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    PMID: 13872198BACKGROUND

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    PMID: 14791307BACKGROUND

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    BACKGROUND

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    BACKGROUND

  • Chaturapit S, Holder GM. Studies on the hepatic microsomal metabolism of (14C) phenanthrene. Biochem Pharmacol. 1978;27(14):1865-71. doi: 10.1016/0006-2952(78)90034-5. No abstract available.

    PMID: 708468BACKGROUND

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    PMID: 14155051BACKGROUND

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    PMID: 14042727BACKGROUND

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    PMID: 14449781BACKGROUND

  • Polynuclear aromatic compounds, Part 1, Chemical, environmental and experimental data. IARC Monogr Eval Carcinog Risk Chem Hum. 1983 Dec;32:1-453. No abstract available.

    PMID: 6586639BACKGROUND

  • Kennaway, E.L. 1924. On the cancer-producing tars and tar-fractions. J. Ind. Hyg. 5: 462-488.

    BACKGROUND

  • LaVoie EJ, Tulley-Freiler L, Bedenko V, Hoffman D. Mutagenicity, tumor-initiating activity, and metabolism of methylphenanthrenes. Cancer Res. 1981 Sep;41(9 Pt 1):3441-7.

    PMID: 7020927BACKGROUND

  • 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.

    BACKGROUND

  • Nordqvist M, Thakker DR, Vyas KP, Yagi H, Levin W, Ryan DE, Thomas PE, Conney AH, Jerina DM. Metabolism of chrysene and phenanthrene to bay-region diol epoxides by rat liver enzymes. Mol Pharmacol. 1981 Jan;19(1):168-78. No abstract available.

    PMID: 7207460BACKGROUND

  • Nousiainen U, Torronen R, Hanninen O. Differential induction of various carboxylesterases by certain polycyclic aromatic hydrocarbons in the rat. Toxicology. 1984 Sep 14;32(3):243-51. doi: 10.1016/0300-483x(84)90077-5.

    PMID: 6089379BACKGROUND

  • Pfeiffer EH. Oncogenic interaction of carcinogenic and non-carcinogenic polycyclic aromatic hydrocarbons in mice. IARC Sci Publ (1971). 1977;(16):69-77.

    PMID: 68911BACKGROUND

  • Rahman A, Barrowman JA, Rahimtula A. The influence of bile on the bioavailability of polynuclear aromatic hydrocarbons from the rat intestine. Can J Physiol Pharmacol. 1986 Sep;64(9):1214-8. doi: 10.1139/y86-205.

    PMID: 3096546BACKGROUND

  • ROE FJ. Effect of phenanthrene on tumour-initiation by 3,4-benzopyrene. Br J Cancer. 1962 Sep;16(3):503-6. doi: 10.1038/bjc.1962.58. No abstract available.

    PMID: 13982333BACKGROUND

  • 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)

    BACKGROUND

  • RTECS (Registry of Toxic Effects of Chemical Substances). 1993. Computer printout.

    BACKGROUND

  • ROE FJ, SALAMAN MH. Further tests for tumour-initiating activity: N, N-di-(2-chloroethyl)-p-aminophenylbutyric acid (CB1348) as an initiator of skin tumour formation in the mouse. Br J Cancer. 1956 Jun;10(2):363-78. doi: 10.1038/bjc.1956.42. No abstract available.

    PMID: 13364128BACKGROUND

  • Salamone, M.F. 1981. Toxicity of 41 carcinogenic analogs. Prog. Mutat. Res. 1: 682-685. (Cited in U.S. EPA, 1988)

    BACKGROUND

  • Sax, N.I. and R.L. Lewis (Eds.). 1987. Hawley's Condensed Chemical Dictionary, 11th ed. Van Nostrand Reinhold Company, New York, p. 895.

    BACKGROUND

  • Scribner JD. Tumor initiation by apparently noncarcinogenic polycyclic aromatic hydrocarbons. J Natl Cancer Inst. 1973 Jun;50(6):1717-9. doi: 10.1093/jnci/50.6.1717. No abstract available.

    PMID: 4123924BACKGROUND

  • Simmon VF, Rosenkranz HS, Zeiger E, Poirier LA. Mutagenic activity of chemical carcinogens and related compounds in the intraperitoneal host-mediated assay. J Natl Cancer Inst. 1979 Apr;62(4):911-8.

    PMID: 372659BACKGROUND

  • Sims P. Qualitative and quantitative studies on the metabolism of a series of aromatic hydrocarbons by rat-liver preparations. Biochem Pharmacol. 1970 Mar;19(3):795-818. doi: 10.1016/0006-2952(70)90243-1. No abstract available.

    PMID: 5507686BACKGROUND

  • STEINER PE. Carcinogenicity of multiple chemicals simultaneously administered. Cancer Res. 1955 Oct;15(9):632-5. No abstract available.

    PMID: 13261089BACKGROUND

  • Storer JS, DeLeon I, Millikan LE, Laseter JL, Griffing C. Human absorption of crude coal tar products. Arch Dermatol. 1984 Jul;120(7):874-7.

    PMID: 6732260BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Stephen S Hecht, Ph.D.

    University of Minnesota Masonic Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2010

First Posted

March 25, 2010

Study Start

September 1, 2007

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 27, 2014

Record last verified: 2014-10

Locations

US(1)