Bupropion as a Smoking Cessation Aid in Alcoholics

Smoking Clinical Trial

Official title:

Bupropion as a Smoking Cessation Aid in Alcoholics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00044434
• Other study ID #: NIAAAGRA13689
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2002
• Last updated: January 25, 2008
• Start date: May 2002
• Est. completion date: April 2005

Study information

• Verified date: January 2008
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2005
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcoholism
• Smoking

Intervention

Drug:
• bupropion (Wellbutrin)

Locations

Country	Name	City	State
United States	VA/Nebraska/Western Iowa Health Care System	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States,