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Bupropion as a Smoking Cessation Aid in Alcoholics

Information source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alcoholism; Smoking

Intervention: bupropion (Wellbutrin) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

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.

Clinical Details

Official title: Bupropion as a Smoking Cessation Aid in Alcoholics

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study

Eligibility

Minimum age: 25 Years. Maximum age: 75 Years. Gender(s): 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.

Locations and Contacts

VA/Nebraska/Western Iowa Health Care System, Omaha, Nebraska 68105, United States
Additional Information

Starting date: May 2002
Ending date: April 2005
Last updated: January 25, 2008

Page last updated: June 20, 2008

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