Bupropion as an Adjunct to the Nicotine Patch Plus CBT
Tobacco Use Disorder
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring nicotine dependence
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
1
2
Bupropion-SR, 150 mg/day x 3 days, then 300 mg/day for 13 weeks
Identical Placebo