This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing
the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from
smoking with nicotine patch therapy. The study will also determine the cessation rate in the
8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is
projected to serve as a 100-percent replacement.
The purpose of this trial was to recruit 292 recovering alcoholic smokers (abstinent from
alcohol for a minimum of 1 year), who want to stop smoking and provide them with 100%
nicotine replacement. The 100% nicotine replacement will be undertaken using a nicotine
patch. By measuring their nicotine levels at study entry we can determine the patch dosing
needed. The patch dosing will vary from 22 mg to 44 mg. Those who are able to achieve
tobacco abstinence by week 8 will enter a relapse prevention phase for the remaining 44
weeks. In this phase, they will be randomized to active or placebo bupropion (300 mg/day).
After 44 weeks of the relapse prevention trial (at week 52 of study participation), they
will enter a post medication follow up for 6 months.
- History of alcohol dependence and at least one year of abstinence from alcohol
- Has a history of smoking 20 or more cigarettes per day for the prior year.
- Can read and write English.
- Stated ability to fully participate in the study and keep all scheduled appointments.
- Has provided written informed consent.
- General good health.
- Recent history (within three months) of a clinically significant myocardial
infarction, unstable angina pectoris, serious cardiac arrhythmia or any other medical
condition which the physician investigator deems incompatible with study
- Current major depression. A past history of major depression will not be an
- Current or previous use of bupropion (Wellbutrin).
- Active non- nicotine drug dependence.
- Past or current history of bipolar disorder, pain disorder or psychosis,
schizophrenia, or other major psychiatric disorders.
- Current medically indicated use of psychiatric drugs.
- Females who are pregnant, lactating, or likely to become pregnant during the first
year which includes the nicotine patch and bupropion (Wellbutrin) phase.
- History of severe skin allergies or evidence of severe chronic skin disorders.
- Current use of nicotine containing medication or tobacco products other than
- Current use (within 30 days of initiation of patch therapy) of the following
medications for smoking cessation: clonidine, buspirone, or doxepin.
- A predisposition to seizures.
- A history of or current diagnosis of anorexia nervosa or bulimia.
- Medical disorder that would interfere with the absorption, metabolism, or excretion
of bupropion (Wellbutrin).