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

Tobacco Toxicant Exposure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01092650
• Other study ID #: 0707M13481
• Status: Completed
• Phase: Phase 1
• First received: March 23, 2010
• Last updated: October 24, 2014
• Start date: September 2007
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tobacco Toxicant Exposure

Intervention

Drug:
• Deuterated phenanthrene
Deuterated phenanthrene 10 micrograms

Locations

Country	Name	City	State
United States	Tobacco Use Research Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Deuterated phenanthrene tetraol ([D10]PheT) assessed post dosing for smoked versus oral administration.	36 hours post dosing	No