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

NCT ID: NCT01092650

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-12-31

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.

Conditions

Tobacco Toxicant Exposure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Smoked

Deuterated Phenanthrene spiked in a study cigarette

Group Type: ACTIVE_COMPARATOR

Deuterated phenanthrene

Intervention Type: DRUG

Deuterated phenanthrene 10 micrograms

Oral

Deuterated phenanthrene in an oral dose

Group Type: EXPERIMENTAL

Deuterated phenanthrene

Intervention Type: DRUG

Deuterated phenanthrene 10 micrograms

Interventions

Deuterated phenanthrene

Deuterated phenanthrene 10 micrograms

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen S Hecht, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota Masonic Cancer Center

Locations

Tobacco Use Research Center

Minneapolis, Minnesota, United States

Countries

United States

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Other Identifiers

0707M13481

Identifier Type: -

Identifier Source: org_study_id