Bupropion as a Smoking Cessation Aid in Alcoholics
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2002
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 28, 2002
CompletedFirst Posted
Study publicly available on registry
August 30, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2005
CompletedJanuary 29, 2008
January 1, 2008
2.9 years
August 28, 2002
January 25, 2008
Conditions
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA/Nebraska/Western Iowa Health Care System
Omaha, Nebraska, 68105, United States
Related Publications (1)
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.
PMID: 37230961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 28, 2002
First Posted
August 30, 2002
Study Start
May 1, 2002
Primary Completion
April 1, 2005
Study Completion
April 1, 2005
Last Updated
January 29, 2008
Record last verified: 2008-01