CompletedPhase 2NCT00534001

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

StatusCompleted
PhasePhase 2
U.S. locations1
SponsorRoswell Park Cancer Institute
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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