Zileuton With or Without Celecoxib As Chemopreventive Agents in Smokers

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Tobacco Use Disorder

Clinical Trial Details

NCT number	NCT01021215
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	May 2010
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT02432066` - Effects of GTS-21 on Smoking Behavior and Neurocognitive Functions	Phase 2
Completed	`NCT03960138` - Examining the Effects of Neural Stimulation on Inhibitory Control and Cigarette Smoking	N/A
Recruiting	`NCT05030272` - Comparing Two Behavioral Approaches to Quitting Smoking in Mental Health Settings	N/A
Completed	`NCT04646668` - Comparative Abuse Liability Among African American and White Smokers	N/A
Completed	`NCT02560324` - Effect of Ramelteon on Smoking Abstinence	Phase 2
Completed	`NCT02347605` - Medicinal Nicotine for Preventing Cue Induced Craving	N/A
Completed	`NCT01428310` - Study to Evaluate the Safety and Efficacy of Dietary Supplement Anatabloc in Reducing Daily Smokers' Urge to Smoke	Phase 1
Terminated	`NCT01800500` - Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers	N/A
Completed	`NCT01570595` - Positively Smoke Free on the Web (PSFW) for Smokers Living With HIV	Phase 1/Phase 2
Completed	`NCT01442753` - Family-Skills Training to Prevent Tobacco and Other Substance Use in Latino Youth	N/A
Completed	`NCT01625767` - Tobacco Approach Avoidance Training for Adolescent Smokers-1	Phase 2
Active, not recruiting	`NCT01539525` - Screening to Augment Referral to Treatment- Project START	Phase 2
Completed	`NCT00967005` - N-Acetyl Cysteine Plus Behavioral Therapy for Nicotine Dependent Pathological Gamblers	Phase 2
Completed	`NCT01337817` - A Pilot Study to Evaluate the Efficacy and Safety of Ariva® Silver Wintergreen in Healthy Smokers	Phase 1
Active, not recruiting	`NCT00751660` - Screening Methods in Finding Lung Cancer Early in Current or Former Smokers	N/A
Completed	`NCT00790569` - Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking	N/A
Completed	`NCT00664261` - Clinical Effort Against Secondhand Smoke (CEASE) Program or Standard Care in Helping Parents Stop Smoking	N/A
Completed	`NCT00218179` - Assessing the Link Between Smoke Carcinogen Biomarkers and Lung Cancer Risk - 1	N/A
Completed	`NCT01213524` - Nicotine and Sensorimotor Replacement for Smoking in Smokers With Schizophrenia	Phase 2
Completed	`NCT00134927` - A Survey on Consumer Use of Over-the-Counter (OTC) Nicotine Patches	N/A