Pharmacologic Relapse Prevention for Alcoholic Smokers

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Alcoholism; Smoking

Treatments: Drug: bupropion (Wellbutrin); Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00000457

972-95

R01AA011219 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 195 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

195 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subjects who achieved smoking abstinence and give a bupropion-placebo (sugar) pill for 44 weeks in order to prevent relapse to smoking. Brief Behavioral Counseling is also given during this time.

Treatment:

Drug: Placebo

Bupropion

Active Comparator group

Description:

Subjects who achieved smoking abstinence and give bupropion (300 mg/day) for 44 weeks in order to prevent relapse to smoking. Brief Behavioral Counseling is also given during this time.

Treatment:

Drug: bupropion (Wellbutrin)