Pharmacologic Relapse Prevention for Alcoholic Smokers

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Bupropion

Criteria

Inclusion Criteria:

• History of alcohol dependence and at least one year of abstinence from alcohol intake.

• 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.

Exclusion Criteria:

• 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 participation.

• Current major depression. A past history of major depression will not be an exclusionary criteria.

• 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 cigarettes.

• 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).