Bupropion as a Smoking Cessation Aid in Alcoholics

NCT ID: NCT00044434

Last Updated: 2008-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-05-31
• Study Completion Date: 2005-04-30

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.

Conditions

Alcoholism; Smoking

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

bupropion (Wellbutrin)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: lead

Locations

VA/Nebraska/Western Iowa Health Care System

Omaha, Nebraska, United States

Countries

United States

References

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type: DERIVED

PMID: 37230961 (View on PubMed)

Other Identifiers

NIAAAGRA13689

Identifier Type: -

Identifier Source: org_study_id