Status:
COMPLETED
Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals
Lead Sponsor:
University of Tennessee
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
Nicotine addiction is a serious health problem in the United States; 46 million people smoke cigarettes, and 70% of those are trying to quit. The nicotine patch and bupropion, a medication used to red...
Detailed Description
Cigarette smoking poses a serious but preventable health risk. The negative health effects of smoking are well-known, but the prevalence of cigarette smoking remains high in the United States, particu...
Eligibility Criteria
Inclusion
- In good health
- In a lower socioeconomic group, defined as below median income in the study county
- Smokes more than 5 cigarettes each day for at least 6 months prior to study entry, as determined by self-report
Exclusion
- History of a seizure disorder, brain tumor, or severe head trauma
- History of substance abuse, including alcohol use in excess of 14 drinks a week
- History of anorexia or bulimia
- History of cerebral, coronary, or peripheral vascular disease
- History of serious heart arrhythmia
- Presence of an unstable psychiatric illness
- Current use of a psychotropic medication, including antidepressant medications
- History of peptic ulcer disease or currently taking an H2 blocker (e.g., cimetidine)
- History of kidney disease, defined as creatinine levels greater than 1.5 times the upper limit of normal
- History of liver disease, defined as serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic-pyruvic transaminase(SGPT) levels greater than twice the upper limit of normal
- History of uncontrolled hyperthyroidism or pheochromocytoma
- History of atopic or eczematous dermatitis
- Current use of a medication that cannot be discontinued and may interfere with study procedures or may increase the risk of side effects (e.g., nicotine gum, nicotine nasal spray, theophylline, systemic steroids, levodopa)
- History of an allergic reaction to the nicotine patch or bupropion
- History of diabetes treated with an oral agent or insulin
- Uncontrolled high blood pressure, defined as blood pressure level greater than 140/90 mm Hg
- Severe uncontrolled asthma, bronchitis, or emphysema
- Pregnant or breastfeeding
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
594 Patients enrolled
Trial Details
Trial ID
NCT00308763
Start Date
January 1 2004
End Date
December 1 2008
Last Update
May 21 2014
Active Locations (1)
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1
University of Tennessee Health Science Center / Department of Preventive Medicine
Memphis, Tennessee, United States, 38105