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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00534001 |
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Date of registration:
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20/09/2007 |
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Primary sponsor: |
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Public title:
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Bupropion in Helping Adults Stop Smoking
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Scientific title:
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A Phase II Study of the Effects of Extended Pre-Cessation Bupropion for Smoking Cessation |
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Date of first enrolment:
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January 2006 |
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Target sample size:
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97 |
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Recruitment status: |
Active, not recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00534001 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Martin Mahoney, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Roswell Park Cancer Institute |
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
- Currently smokes = 15 cigarettes per day for at least 1 year
- Motivated to quit smoking within the next 3 months
PATIENT CHARACTERISTICS:
- Willing to attend clinic visits
- Willing to refrain from nicotine replacement therapy (NRT) use during study
participation
- Able to speak and read English fluently
- Has a home telephone and plans to reside in Western New York for the next year
- Not pregnant or nursing
- Negative pregnancy test
- Not planning a pregnancy
- Fertile patients must use effective contraception during and for 3 months after study
participation
- No history of chronic renal or hepatic disease
- No history of head trauma or seizure
- No history of a seizure disorder, brain tumor, or CNS tumor
- No history of or currently diagnosed bulimia or anorexia nervosa
- No history of psychotic disorder
- No diabetes requiring oral hypoglycemics or insulin
- No excessive use of alcohol or alcoholism
- No current addiction to opiates, cocaine, or stimulants
- No poorly controlled hypertension (i.e., systolic blood pressure [BP] > 170 mm Hg
and/or diastolic BP > 110 mm Hg)
- No allergy to bupropion hydrochloride
- No other surgical or medical condition that may significantly alter absorption,
distribution, metabolism, or excretion of bupropion hydrochloride
- No history of noncompliance to medical regimens
- No other clinical contraindication
- No major depressive disorder
PRIOR CONCURRENT THERAPY:
- At least 14 days since prior and no concurrent monoamine oxidase inhibitor
- No recent discontinuation of a benzodiazepine
- No concurrent Hypericum perforatum (St. John's wort)
- No other concurrent drugs containing bupropion hydrochloride (e.g., Wellbutrin or
Zyban)
- No concurrent antipsychotics, antidepressants, theophylline, systemic steroids,
over-the-counter stimulants or anorectics, or levodopa
- No concurrent active treatment for cancer (e.g., chemotherapy or radiotherapy)
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Bladder Cancer
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Cervical Cancer
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Esophageal Cancer
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Gastric Cancer
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Head and Neck Cancer
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Kidney Cancer
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Leukemia
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Liver Cancer
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Lung Cancer
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Pancreatic Cancer
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Tobacco Use Disorder
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Intervention(s)
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Drug: bupropion hydrochloride
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Other: placebo
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Primary Outcome(s)
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Effect of bupropion hydrochloride on changes in smoking behavior as well as smoking satisfaction, craving, and withdrawal as determined during the pre-cessation phase
[Time Frame: 4 weeks]
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Role of pre-cessation bupropion hydrochloride effects in smoking cessation
[Time Frame: 4 weeks]
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Secondary ID(s)
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CDR0000565103
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I 57805
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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