Bupropion in Helping Adults Stop Smoking
RATIONALE: Bupropion may help people stop smoking by decreasing the symptoms of nicotine withdrawal. Giving bupropion over a longer period of time may be effective in helping people stop smoking. PURPOSE: This randomized phase II trial is studying how well bupropion works in helping adults stop smoking.
Checked against the public recordLast updated May 30, 2017 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Other
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Roswell Park Cancer Institute
- Interventions being studied
- Drug: bupropion hydrochloride; Other: placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
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)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Roswell Park Cancer InstituteBuffalo, New York
Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 30, 2017. Always confirm current availability with the study team.