Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
18 Years
65 Years
Both
Tobacco Toxicant Exposure
Trial Information
Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
Outcome Measure:
Pharmacokinetics
Outcome Description:
Deuterated phenanthrene tetraol ([D10]PheT) assessed post dosing for smoked versus oral administration.
Outcome Time Frame:
36 hours post dosing
Safety Issue:
No
Principal Investigator
Stephen S Hecht, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Minnesota Masonic Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
0707M13481
NCT ID:
NCT01092650
Start Date:
September 2007
Completion Date:
December 2014
Related Keywords:
- Tobacco Toxicant Exposure
- Tobacco toxicants
- Polycyclic aromatic hydrocarbons
- Smoking
Name | Location |
|---|---|
| Tobacco Use Research Center | Minneapolis, Minnesota 55414 |
