Clinical trial NCT00308763: Nicotine Patch and Bupropion to Reduce Smoking Rates in Younger, Low-Income, and Minority Individuals
Official title: Clinical Trial of Two Medications on Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Keywords: Smoking Cessation
Nicotine Dependence
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-03-30
Enrollment: 594
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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, particularly among younger people, people of lower socioeconomic status, and minority groups. Nicotine replacement therapy, commonly known as the nicotine patch, has been proven to be an effective treatment for reducing nicotine use. The nicotine patch provides a measured dose of nicotine through the skin. By gradually lowering nicotine doses over a period of time, individuals experience fewer nicotine cravings; the ultimate goal is to stop using nicotine. Bupropion, a medication commonly used to treat depression, is also used as a smoking cessation tool. It helps to control nicotine cravings. The majority of studies on the nicotine patch and bupropion have been performed on older, white, middle-class individuals; more research is needed to confirm the benefit of these treatments in younger, low-income, and minority populations. While both the nicotine patch and bupropion appear to be individually effective as smoking cessation aids, little is known on the possible effectiveness of combining the two treatments. Because of the high relapse rates in low-income and minority individuals, the combination of the nicotine patch with bupropion may be particularly effective at reducing relapse rates in these individuals. The purpose of this study is to evaluate the effectiveness of the nicotine patch and bupropion at reducing smoking rates in younger, low-income, and minority individuals.

This 1-year study will enroll younger, low-income, and minority individuals who smoke. Participants will be randomly assigned to one of the following three groups: 1) nicotine patch plus placebo sustained-release bupropion; 2) placebo nicotine patch plus sustained-release bupropion; or 3) nicotine patch plus sustained-release bupropion. At study entry, participants will complete standardized psychological questionnaires to assess depression levels and will undergo a physical exam and blood testing. Study visits will take place at Weeks 5 and 11, Month 6, and Year 1. At each visit, questionnaires will be completed, and smoking cessation rates will be assessed by self-report and verified by saliva and exhaled carbon monoxide testing. In addition, all participants will take part in a standardized behavioral smoking cessation program.

Eligibility 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

Primary outcomes:
measure: Smoking cessation rates (measured by self-report, saliva test, and exhaled carbon monoxide test)
timeFrame: Measured at 1 year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: University of Tennessee Health Science Center / Department of Preventive Medicine
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Karen C. Johnson, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Badrun F, Tolley B, Johnson KC. Smoking Cessation Interventions and Their Effects on Mood and Quit Pattern. In preparation 2014.