Clinical trial NCT01092650: Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
Official title: Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Toxicant Exposure
Keywords: Tobacco toxicants
Polycyclic aromatic hydrocarbons
Smoking
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2010-03-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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 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.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 36 hours post dosing
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Tobacco Use Research Center
state: Minnesota
Study officials:
affiliation: University of Minnesota Masonic Cancer Center
name: Stephen S Hecht, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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