AlcoholismPhase 4NCT00044434
Bupropion as a Smoking Cessation Aid in Alcoholics
A Phase 4 study testing bupropion (Wellbutrin) in people with Alcoholism and Smoking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Alcoholism, Smoking
- What is being tested?
- bupropion (Wellbutrin)
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Apr 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA/Nebraska/Western Iowa Health Care System
Omaha, Nebraska, 68105
About this study
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
- Being tested
- bupropion (Wellbutrin)
- Medical subject headings
- Alcoholism, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion (Wellbutrin)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2002 (estimated)
- Study startMay 2002
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00044434
- Sponsor's protocol ID
- NIAAAGRA13689
- Status last verified
- Jan 2008
- First submitted
- 28 Aug 2002
- Last updated
- 29 Jan 2008
- Results posted
- No
Publications
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.
PubMed 37230961
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion as a Smoking Cessation Aid in Alcoholics
- ClinicalTrials.gov ID
- NCT00044434
- Acronym / sponsor ID
- NIAAAGRA13689
- Conditions
- Alcoholism, Smoking
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)US National Institutes of Health
- Study start
- May 2002
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 30 Aug 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupropion (Wellbutrin) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2008.
- Derived from this study: PubMed 37230961Hajizadeh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing bupropion (Wellbutrin) in people with Alcoholism and Smoking, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00044434, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2008.