Status:
COMPLETED
Bupropion as an Adjunct to the Nicotine Patch Plus CBT
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief Summary
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 o...
Detailed Description
Smoking cessation treatment is highly cost effective and pharmacotherapy is universally recommended for treatment of nicotine dependence. However, the majority of smokers are unable to quit even with ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
293 Patients enrolled
Trial Details
Trial ID
NCT00142831
Start Date
April 1 1999
End Date
August 1 2006
Last Update
January 12 2017
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114