Bupropion in Helping Adults Stop Smoking

Study summary

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.

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Key things to know

Main goalOther

This describes the study’s primary purpose.

What is being studiedbupropion hydrochloride and placebo

The study team can explain what participation involves.

Who it may be forBladder Cancer · Cervical Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 30, 2017 · Source: ClinicalTrials.gov

Is enrollment open?Completed

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What kind of study?Phase 2

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Roswell Park Cancer Institute

Study sponsor

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

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How this study is categorized

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

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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.

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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