Bupropion as an Adjunct to the Nicotine Patch Plus CBT

Completed · Phase 4 · Has a placebo group

Conditions studied: Tobacco Use Disorder

In brief

Existing and new pharmacotherapies along with prevention efforts are key to improving smoking cessation rates and reducing the premature morbidity and mortality associated with tobacco use. A number of individuals suffer from both nicotine dependence and depression. The purpose of this study is to determine the effectiveness of bupropion used in combination with the nicotine replacement patch and cognitive behavior therapy (CBT) in treating nicotine dependent individuals also diagnosed with depression.

Key facts

Study ID

NCT00142831

Run by

National Institute on Drug Abuse (NIDA)

People needed

293

Starts

1999-04-01

Expected to finish

2006-08-01

Last updated by the study team

2017-01-12

Who can join

Age: 20 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Smokes at least 10 cigarettes per day for at least the past 2 years
• Meets DSM-IV criteria for nicotine dependence, as determined by the Fagerstrom Nicotine Tolerance Questionnaire
• Meets DSM-IV diagnoses of unipolar depressive disorders (major depression, dysthymia, and minor depression)

You may not qualify if…

• Current suicidal or homicidal risk
• Serious illness, including cardiovascular, liver, kidney, respiratory, endocrine, neurologic, or hematologic disease
• Untreated peptic ulcer
• Life-threatening arrhythmia, cerebrovascular, or cardiovascular event within the 6 months prior to enrollment
• Severe respiratory compromise, as defined as a FEV-1 less than 1.0 L/min and/or pO2 less than 60 or pCO2 less than 45
• Currently using nicotine-containing products (e.g., cigar, pipe, snuff, nicotine gum)
• History of a seizure disorder
• Current DSM-IV diagnosis of organic mental disorder, schizophrenia, delusional disorder, psychotic disorder, bipolar disorder, or antisocial personality disorder
• Current DSM-IV diagnosis of substance abuse or dependence disorders within the year prior to enrollment
• Current eating disorder, including anorexia nervosa and bulimia nervosa
• History of multiple adverse drug reactions or allergy to bupropion
• Mood congruent or mood incongruent psychotic features
• Current use of other psychotropic drugs (with the exception of hypnotics and benzodiazepines at stable doses for at least six months prior to enrollment or current use of nonbenzodiazepine hypnotics such as Ambien and Sonata)
• Clinical or laboratory evidence of hypothyroidism
• Currently seeking treatment for smoking cessation
• History of skin diseases (e.g., psoriasis), skin allergies, or strong reactions to topical preparations, medical dressings, or tapes
• Currently using topical drugs
• Pregnant
• Not using adequate methods of contraception

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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