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Bupropion as a Smoking Cessation Aid in Alcoholics

Bupropion as a Smoking Cessation Aid in Alcoholics

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00044434
Enrollment
200
Registered
2002-08-30
Start date
2002-05-31
Completion date
2005-04-30
Last updated
2008-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcoholism, Smoking

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.

Interventions

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead SponsorNIH

Study design

Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
No

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026