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Bupropion as a Smoking Cessation Aid in Alcoholics

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion (Wellbutrin)
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

25 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope. Have a diagnosis of alcohol abuse or alcohol dependence. Smoke 20 or more cigarettes/day (may also smoke pipes/cigars). Be interested in quitting smoking. Provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period. If female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study. Agree to sign informed consent. Able to read and understand study-related forms and procedures. Exclusion Criteria: Advanced cardiac, pulmonary, renal, or liver disease. History of seizures. History of brain tumor or significant head trauma. History of bulimia or anorexia nervosa. Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder. Using psychoactive drugs. Receiving treatment with medications that lower seizure thresholds. Use of an investigational drug in any study in the past four weeks. Currently using any asthma medication. Used time-released bupropion in the past 12 months. Currently using any other treatments to stop smoking.

Sites / Locations

  • VA/Nebraska/Western Iowa Health Care System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 28, 2002
Last Updated
January 25, 2008
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00044434
Brief Title
Bupropion as a Smoking Cessation Aid in Alcoholics
Official Title
Bupropion as a Smoking Cessation Aid in Alcoholics
Study Type
Interventional

2. Study Status

Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to test the use of time-released bupropion (Wellbutrin) in patients receiving treatment for alcohol abuse/dependence as an aid to stop smoking. Patients will receive either a time-released bupropion or placebo. Both groups will receive nicotine replacement therapy during the 9 week study. A final followup assessment will be conducted 6 months from the start of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Masking
Double
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bupropion (Wellbutrin)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Currently a patient in the Omaha VA Medical Center, Substance Abuse Treatment Center (SATC) or at Catholic Charities Campus for Hope. Have a diagnosis of alcohol abuse or alcohol dependence. Smoke 20 or more cigarettes/day (may also smoke pipes/cigars). Be interested in quitting smoking. Provide name, addresses, and phone numbers of at least two individuals who can provide information on their alcohol, nicotine, and other drug use during the follow-up period. If female, patient must a) be of non-childbearing potential, b) have a negative pregnancy test, c) sign a document stating they do not plan on becoming pregnant during the study. Agree to sign informed consent. Able to read and understand study-related forms and procedures. Exclusion Criteria: Advanced cardiac, pulmonary, renal, or liver disease. History of seizures. History of brain tumor or significant head trauma. History of bulimia or anorexia nervosa. Current major depressive disorder or past history of panic disorders, schizophrenia, or bipolar affective disorder. Using psychoactive drugs. Receiving treatment with medications that lower seizure thresholds. Use of an investigational drug in any study in the past four weeks. Currently using any asthma medication. Used time-released bupropion in the past 12 months. Currently using any other treatments to stop smoking.
Facility Information:
Facility Name
VA/Nebraska/Western Iowa Health Care System
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68105
Country
United States

12. IPD Sharing Statement

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Bupropion as a Smoking Cessation Aid in Alcoholics

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