Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

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 reduce nicotine cravings, are two commonly used smoking cessation aids. Both have been shown to reduce smoking rates, however, the effectiveness of combining the two treatments has not been widely examined. This study will evaluate the effectiveness of the nicotine patch combined with bupropion at reducing smoking rates among younger, low-income, and minority individuals.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Tennessee
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Bupropion; Nicotine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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