Conditions: Tobacco Use Disorder
Keywords: Cancer Prevention Smoking-related lung disease Smoking Celecoxib Celebrex Zileuton Zyflo CR Prevention
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
The goal of this clinical research study is to learn how zileuton alone or the combination of zileuton and celecoxib may affect certain chemicals in the body that may be linked with a risk for smoking-related lung disease. These effects will be measured by a urine test

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether short-term administration of zileuton, a 5-lipoxygenase (5-LO) inhibitor, in current smokers will suppress the formation of urinary leukotriene E4 (LTE4) and shunt arachidonic acid into the cyclooxygenase (COX) pathway, resulting in elevated urinary prostaglandin E-metabolite (PGE-M).

SECONDARY OBJECTIVES:

I. To determine whether short-term co-administration of celecoxib, a selective COX-2 inhibitor, and zileuton suppresses levels of both urinary LTE4 and PGE-M in current smokers.

II. To evaluate the association between baseline levels of urinary LTE4 and magnitude of the arachidonic acid shunt induced by zileuton.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive zileuton orally (PO) twice daily (BID) on days 1-6.

ARM II: Patients receive zileuton as in Arm I and celecoxib PO BID on days 1-6.

Arms:
arm 1: Zileuton 1200 mg twice orally twice a day on days 1-6. arm 2: Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.

Interventions: intervention 1: Zileuton intervention 2: Celecoxib intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: 1200 mg twice daily given orally (PO) for 6 days intervention 2: 200 mg twice daily given orally for 6 days intervention 3: Correlative studies

Protocol document: