Overview

Maintaining Abstinence in Chronic Cigarette Smokers - 1

Status:
Completed
Trial end date:
2009-09-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the extended pharmacological and psychological treatment for chronic cigarette smokers.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Treatments:
Bupropion
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