Status:
COMPLETED
Maintaining Abstinence in Chronic Cigarette Smokers - 1
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.
Detailed Description
The work adapts interventions that have been successful in the general populations, and tailors them to chronic smokers, who may have numerous previous smoking treatment failures. If successful it wil...
Eligibility Criteria
Inclusion
- Subjects (N=400) will be men and women (50%) over the age of 18 who smoke at least 10 cigarettes per day and answers yes to the question "Do you smoke within 30 minutes of arising?"
- Subjects are age 18 and over, currently smoking 10 or more cigarettes per day, and report a smoking history of at least 5 years in response to the question "How long have you been a regular smoker?"
Exclusion
- History of seizure or head injury resulting in unconsciousness
- Any condition that might predispose to seizures (brain tumor or stroke)
- A current or history of anorexia nervosa or bulimia
- Any disease acutely life-threatening or so severe that the patient is judged unable to comply with the protocol
- Use of a protease inhibitor of MAO inhibitor within the last two week
- Current use of psychiatric drugs that would interfere with interpretation of study results, including antidepressants
- Treatment for alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol
- Patients who know they are leaving the Bay Area within the study period and non-English speakers will be excluded
- Suicidal or homicidal ideation
- Current major depression
- History of bipolar disorder
- Recent (within twelve months) myocardial infarction
- Any other medical condition that would contraindicate use of NRT or bupropion
- Physical limitation so severe that participation in a program of moderate exercise is not possible
- Pregnancy or lactation
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
407 Patients enrolled
Trial Details
Trial ID
NCT00087880
Start Date
December 1 2002
End Date
September 1 2009
Last Update
January 12 2017
Active Locations (1)
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1
University California, San Francisco
San Francisco, California, United States, 94143-0984