Bupropion as a Smoking Cessation Aid in Alcoholics
This study has been completed.
Information provided by:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First received: August 28, 2002
Last updated: January 25, 2008
Last verified: January 2008
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.
Drug: bupropion (Wellbutrin)
Endpoint Classification: Safety/Efficacy Study
Primary Purpose: Treatment
||Bupropion as a Smoking Cessation Aid in Alcoholics
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2005 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||25 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044434
|VA/Nebraska/Western Iowa Health Care System
|Omaha, Nebraska, United States, 68105 |
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 28, 2002
||January 25, 2008
||United States: Federal Government
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs