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Pharmacologic Relapse Prevention for Alcoholic Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000457
First Posted: November 3, 1999
Last Update Posted: October 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:
Mayo Clinic
  Purpose
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.

Condition Intervention Phase
Alcoholism Smoking Drug: bupropion (Wellbutrin) Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pharmacologic Relapse Prevention for Alcoholic Smokers

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 195
Study Start Date: June 1998
Study Completion Date: August 2007
Primary Completion Date: April 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • zyban
  • wellbutrin
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
  • zyban
  • wellbutrin

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000457


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Richard D Hurt, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Richard D. Hurt, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00000457     History of Changes
Other Study ID Numbers: 972-95
R01AA011219 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 1999
First Posted: November 3, 1999
Last Update Posted: October 21, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors