Maintaining Abstinence in Chronic Cigarette Smokers
Bupropion and NRT
Mental Disorders+1
+ Tobacco Use Disorder
+ Substance-Related Disorders
Treatment Study
Summary
Study start date: December 1, 2002
Actual date on which the first participant was enrolled.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 will: (1) make available a treatment intervention that produces hight long term abstinence rates; (2) provide information on variables that predicts success and failure in this population of smokers; (3) examine the cost-effectiveness of more intensive, longer term treatments.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.407 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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?" Inclusion Criteria: -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 Criteria: * 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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.5 intervention groups are designated in this study
40% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
Active ComparatorGroup IV
PlaceboGroup 5
PlaceboStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location