Overview

Bupropion in Helping Adults Stop Smoking

Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Roswell Park Cancer Institute
Treatments:
Bupropion
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)