SchizophreniaPhase 2NCT00218231
Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia
A Phase 2 study testing 300 mg/day bupropion-sr and 0 mg/day bupropion-sr in people with Schizophrenia and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 2 sites in United States.
Trial summary
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Tobacco Use Disorder
- What is being tested?
- 300 mg/day bupropion-sr and 0 mg/day bupropion-sr
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2004to Aug 2006
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosed with schizophrenia or schizo-affective disorder
- Smokes between 20 and 50 cigarettes per day
- Moderate to high nicotine dependence score
- Interest in quitting smoking
Who cannot join
- Currently trying to quit smoking
- Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
- Alcohol or drug use disorders
- Requires certain medications
- Pregnant or breastfeeding
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Providence VA Medical Center, RI
Providence, Rhode Island, 02908
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.
Read the detailed description
There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).
Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.
- Conditions
- Schizophrenia, Tobacco Use Disorder
- Being tested
- 300 mg/day bupropion-sr, 0 mg/day bupropion-sr
- Keywords
- schizophrenia, tobacco dependence, nicotine
- Medical subject headings
- Schizophrenia, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
300 mg/day bupropion-srDrug
Also called zyban, wellbutrin
300 mg/day for 1 week
0 mg/day bupropion-srDrug
Also called placebo
0 mg/day bupropion-sr
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 300 mg/day bupropion-sr Receives: Drug: 300 mg/day bupropion-sr |
| 2 | Placebo comparator | 0 mg bupropion-sr Receives: Drug: 0 mg/day bupropion-sr |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking behavior
Measured: after 5 hrs abstinence
Secondary outcomes (3)
Adverse events
Measured: ongoing
urge to smoke
Measured: after 5 hrs abstinence
nicotine withdrawal symptoms
Measured: after 5 hrs withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJan 2004
- Primary completionAug 2006
- Study completionAug 2006
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 SchizophreniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Jennifer W. Tidey, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218231
- Sponsor's protocol ID
- NIDA-14002-2
- Other IDs
- R01-14002-2, DPMC
- Status last verified
- Aug 2008
- First submitted
- 16 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- 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 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transdermal Nicotine and Bupropion-SR in Schizophrenics (Study 2)
- ClinicalTrials.gov ID
- NCT00218231
- Acronym / sponsor ID
- NIDA-14002-2
- Conditions
- Schizophrenia, Tobacco Use Disorder
- Keywords
- schizophrenia, tobacco dependence, nicotine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jan 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 22 Sep 2005 (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.
Many individuals with schizophrenia smoke cigarettes but little is known about the factors that control smoking in people with schizophrenia. The purpose of this trial is to evaluate how bupropion, an antidepressant medication, affects smoking behaviors in individuals with schizophrenia who smoke.
Detailed description
There is a high prevalence of cigarette smoking among people with schizophrenia and few smoking cessation interventions have been developed for these individuals. Bupropion is an antidepressant medication commonly used to treat smoking in smokers without psychiatric disorder. This study compares how smokers with schizophrenia and smokers without psychiatric illness respond to bupropion (0, 300 mg/day).
Participants will be randomly assigned to receive either bupropion or placebo. Study visits will occur after one-week treatment with placebo or bupropion. During study sessions, participants will come to the laboratory at 9 am and will remain abstinent in the laboratory for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after viewing and handling neutral cues and smoking cues. After that, participants will have a 90-min period to smoke, and smoking topography will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 300 mg/day bupropion-sr300 mg/day bupropion-sr |
| 2 | Placebo comparator | Drug: 0 mg/day bupropion-sr0 mg bupropion-sr |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with schizophrenia or schizo-affective disorder
- Smokes between 20 and 50 cigarettes per day
- Moderate to high nicotine dependence score
- Interest in quitting smoking
Key exclusion criteria (5 listed)
- Currently trying to quit smoking
- Seizure disorder or lowered seizure threshold due to anorexia, bulimia, head trauma, diabetes with insulin, or hypoglycemics
- Alcohol or drug use disorders
- Requires certain medications
- Pregnant or breastfeeding
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 |
|---|---|---|
| 300 mg/day bupropion-srAlso: zyban, wellbutrin300 mg/day for 1 week | Drug | 1 |
| 0 mg/day bupropion-srAlso: placebo0 mg/day bupropion-sr | Drug | 2 |
Primary outcome
Smoking behavior
Time frame: after 5 hrs abstinence
3 secondary outcomes
Adverse events
Time frame: ongoing
urge to smoke
Time frame: after 5 hrs abstinence
nicotine withdrawal symptoms
Time frame: after 5 hrs withdrawal
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 12 Jan 2017.
- 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.
Jennifer W. Tidey principal investigator
Brown University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 300 mg/day bupropion-sr and 0 mg/day bupropion-sr in people with Schizophrenia and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA) at 2 sites 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 4 inclusion and 5 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 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Smoking behavior (time frame: after 5 hrs abstinence). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00218231, 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 12 Jan 2017.