Determining Levels of [D10] Phenanthrene Tetraol in Smokers' Urine
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ClinicalTrials.gov Identifier: NCT01092650 |
Recruitment Status
:
Completed
First Posted
: March 25, 2010
Last Update Posted
: October 27, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tobacco Toxicant Exposure | Drug: Deuterated phenanthrene | Phase 1 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
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 |
Study Start Date : | September 2007 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Smoked
Deuterated Phenanthrene spiked in a study cigarette
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Drug: Deuterated phenanthrene
Deuterated phenanthrene 10 micrograms
|
Experimental: Oral
Deuterated phenanthrene in an oral dose
|
Drug: Deuterated phenanthrene
Deuterated phenanthrene 10 micrograms
|
- Pharmacokinetics [ Time Frame: 36 hours post dosing ]Deuterated phenanthrene tetraol ([D10]PheT) assessed post dosing for smoked versus oral administration.

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

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
United States, Minnesota | |
Tobacco Use Research Center | |
Minneapolis, Minnesota, United States, 55455 |
Principal Investigator: | Stephen S Hecht, Ph.D. | University of Minnesota Masonic Cancer Center |
Publications:
Responsible Party: | University of Minnesota - Clinical and Translational Science Institute |
ClinicalTrials.gov Identifier: | NCT01092650 History of Changes |
Other Study ID Numbers: |
0707M13481 |
First Posted: | March 25, 2010 Key Record Dates |
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 |