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)