Bupropion SR |
Budeprion SR; Wellbutrin SR |
Clinical Trial: Bupropion as a Smoking Cessation Aid in Alcoholics
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Alcoholism Smoking | Drug: bupropion (Wellbutrin) | Phase IV |
MedlinePlus related topics: Alcoholism; Smoking
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Expected Total Enrollment: 200
Study completion: April 2004
Eligibility
Ages Eligible for Study: 25 Years - 75 Years, Genders Eligible for Study: Both
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.
Location Information
Nebraska
VA/Nebraska/Western Iowa Health Care System, Omaha, Nebraska, 68105, United States
More Information
Record last reviewed: November 2004
Last Updated: November 15, 2004
Record first received: August 28, 2002
ClinicalTrials.gov Identifier: NCT00044434
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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