Pharmacologic Relapse Prevention for Alcoholic Smokers

October 18, 2013 updated by: Mayo Clinic
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
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.
Drug: Placebo
placebo pill to match (look alike) the 150 mg pill of the bupropion given in the am for 3 days and then two pills (one in the morning and one at night) for the subsequent 44 mg.
Other Names:
  • bupropion
  • wellbutrin
  • zyban
Active Comparator: Bupropion
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.
Drug: bupropion (Wellbutrin)

1 pill in the am of 150 mg of Bupropion

1 pill (150 mg) in the AM and one in the PM for a total of 300 mg per day for subsequent 44 weeks.

Other Names:
  • bupropion
  • wellbutrin
  • zyban

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Will bupropion reduce relapse to smoking compared to placebo
Time Frame: 52 weeks and 76 weeks
Determine if long-term use of bupropion will reduce the rate of relapse to smoking compared to placebo in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy projected to achieve 100% replacement.
52 weeks and 76 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does matching the dose of nicotine patches to nicotine levels help increase smoking abstinence
Time Frame: 8 weeks
Determine the week 8 smoking cessation rate in recovering alcoholics provided a nicotine patch dose projected to achieve 100% replacement.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

  • Principal Investigator: Richard D Hurt, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 1998

Primary Completion (Actual)

April 1, 2002

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

November 2, 1999

First Posted (Estimate)

November 3, 1999

Study Record Updates

Last Update Posted (Estimate)

October 21, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 972-95
  • R01AA011219 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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