Expired Study
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Omaha, Nebraska 68105


Purpose:

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.


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.


Study is Available At:


Original ID:

NIAAAGRA13689


NCT ID:

NCT00044434


Secondary ID:


Study Acronym:


Brief Title:

Bupropion as a Smoking Cessation Aid in Alcoholics


Official Title:

Bupropion as a Smoking Cessation Aid in Alcoholics


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

25 Years


Maximum Age:

75 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:


Study Dates

Start Date:May 2002
Completion Date:April 2005
Completion Type:Actual
Primary Completion Date:April 2005
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:January 25, 2008
First Received Date:August 28, 2002

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:bupropion (Wellbutrin)

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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