Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT00079469
Eligibility Criteria:
DISEASE CHARACTERISTICS:
* Diagnosis of cancer at least 6 months before study entry
* No carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or CNS tumor
* Smoking history of at least 2 years
* Smoked cigarettes daily for the past 30 days
* Completed prior cancer treatment at least 6 months, but no more than 5 years before study entry
* Concurrent tamoxifen allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Platelet count ≥ 100,000 - 450,000/mm\^3
* WBC ≥ 3,000/mm\^3
Hepatic
* AST and ALT ≤ 2 times upper limit of normal
* Bilirubin ≤ 2.0 mg/dL
Renal
* Creatinine \< 2.0 mg/dL
Cardiovascular
* No unstable cardiovascular disease, including any of the following:
* High-grade atrioventricular block
* Neurocardiogenic syncope
* Unstable angina
* Uncompensated congestive heart failure
* Poorly controlled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Able to undergo peripheral blood draw
* No port-a-cath or Hickman catheters
* Planning to reside in the Washington D.C. metro area for at least 1 year after study entry
* Willing to undergo urine testing for cotinine levels and breath testing for carbon monoxide monitoring
* No significant physical or psychological disability that would preclude study participation
* No known allergy to bupropion
* Baseline urine drug screen negative
* Prescribed pain medication allowed
* None of the following predisposing factors that may increase the risk of seizures with bupropion use:
* History of seizures
* Alcohol use \> 4 oz/day
* History of closed head injury
* History of an eating disorder
* CNS infection
* No poorly controlled diabetes
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* See Disease Characteristics
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 2 years since prior alcohol abuse or substance abuse therapy (except for tobacco use or dependence)
* More than 14 days since prior monoamine oxidase (MAO) inhibitor
* No concurrent MAO inhibitor
* No concurrent bupropion (Wellbutrin® or Wellbutrin SR®)
* No concurrent alcohol or substance abuse disorder treatment
* No concurrent nicotine replacement therapy
* No concurrent medications that lower seizure threshold (e.g., theophylline or short-acting benzodiazepines)
* No use of tobacco products (more than 1 time per week) other than cigarettes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00079469
Study Brief:
Protocol Section:
NCT00079469