Schizophrenia and Disorders With Psychotic FeaturesPhase 2NCT00136760
Contingent Incentives Plus Bupropion for Smoking in People With Schizophrenia
A Phase 2 study testing Bupropion and non-contingent reinforcement plus bupropion in people with Schizophrenia and Disorders With Psychotic Features and Tobacco Use Disorder, run by Brown University at 1 site in United States.
Trial summary
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia and Disorders With Psychotic Features, Tobacco Use Disorder
- What is being tested?
- Bupropion and non-contingent reinforcement plus bupropion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Mar 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications
Who cannot join
- Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incentives Plus Bupropion for Smoking in Schizophrenics
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.
Read the detailed description
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.
- Being tested
- Bupropion, Contingent reinforcement plus placebo, non-contingent reinforcement plus bupropion, Non-contingent reinforcement plus placebo
- Keywords
- tobacco
- Medical subject headings
- Schizophrenia Spectrum and Other Psychotic Disorders, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
Also called zyban, wellbutrin
Contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Contingent reinforcement plus placeboDrug
contingent reinforcement plus placebo (3 weeks)
non-contingent reinforcement plus bupropionDrug
Also called zyban, wellbutrin
non-contingent reinforcement plus bupropion (300 mg/day for 3 weeks)
Non-contingent reinforcement plus placeboDrug
Non-contingent reinforcement plus placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Contingent reinforcement plus bupropion Receives: Drug: Bupropion |
| 2 | Experimental | Contingent reinforcement plus placebo Receives: Drug: Contingent reinforcement plus placebo |
| 3 | Experimental | Non-contingent reinforcement plus bupropion Receives: Drug: non-contingent reinforcement plus bupropion |
| 4 | Placebo comparator | Non-contingent reinforcement plus placebo Receives: Drug: Non-contingent reinforcement plus placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary Cotinine
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
Measured: 3 weeks
Secondary outcomes (1)
Cigarettes Smoked Per Day
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2005 (estimated)
- Study startSep 2003
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Disorders With Psychotic FeaturesStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jennifer Tidey, Brown University
- Investigators
- Jennifer W. Tidey, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00136760
- Sponsor's protocol ID
- NIDA-17566-1
- Other IDs
- R01DA017566, R01-17566-1
- Status last verified
- Apr 2013
- First submitted
- 25 Aug 2005
- Last updated
- 7 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl). 2011 Sep;217(2):279-87. doi: 10.1007/s00213-011-2282-8. Epub 2011 Apr 8.
PubMed 21475970Tidey JW. Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Prev Med. 2012 Nov;55 Suppl(Suppl):S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9.
PubMed 22197799
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentives Plus Bupropion for Smoking in Schizophrenics
- ClinicalTrials.gov ID
- NCT00136760
- Acronym / sponsor ID
- NIDA-17566-1
- Keywords
- tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2003
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 29 Aug 2005 (estimated)
- Results
- Posted 17 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.
Detailed description
There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: BupropionContingent reinforcement plus bupropion |
| 2 | Experimental | Drug: Contingent reinforcement plus placeboContingent reinforcement plus placebo |
| 3 | Experimental | Drug: non-contingent reinforcement plus bupropionNon-contingent reinforcement plus bupropion |
| 4 | Placebo comparator | Drug: Non-contingent reinforcement plus placeboNon-contingent reinforcement plus placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications
Key exclusion criteria (1 listed)
- Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants
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 |
|---|---|---|
| BupropionAlso: zyban, wellbutrinContingent reinforcement plus bupropion (300 mg/day for 3 weeks) | Drug | 1 |
| Contingent reinforcement plus placebocontingent reinforcement plus placebo (3 weeks) | Drug | 2 |
| non-contingent reinforcement plus bupropionAlso: zyban, wellbutrinnon-contingent reinforcement plus bupropion (300 mg/day for 3 weeks) | Drug | 3 |
| Non-contingent reinforcement plus placeboNon-contingent reinforcement plus placebo | Drug | 4 |
Primary outcome
Urinary Cotinine
Time frame: 3 weeks
Urinary Cotinine levels at Week 4 (average of last 3 study visits)
1 secondary outcome
Cigarettes Smoked Per Day
Time frame: 3 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21475970Tidey JW, Rohsenow DJ, Kaplan GB, Swift RM, Reid N. Effects of contingency management and bupropion on cigarette smoking in smokers with schizophrenia. Psychopharmacology (Berl). 2011 Sep;217(2):279-87. doi: 10.1007/s00213-011-2282-8. Epub 2011 Apr 8.
- Results publication: PubMed 22197799Tidey JW. Using incentives to reduce substance use and other health risk behaviors among people with serious mental illness. Prev Med. 2012 Nov;55 Suppl(Suppl):S54-60. doi: 10.1016/j.ypmed.2011.11.010. Epub 2011 Dec 9.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion and non-contingent reinforcement plus bupropion in people with Schizophrenia and Disorders With Psychotic Features and Tobacco Use Disorder, run by Brown University 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 1 inclusion and 1 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 7 Oct 2015. 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. 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?
Yes. Results are posted in the registry (first posted 17 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Urinary Cotinine (time frame: 3 weeks). 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 NCT00136760, which also lists 2 linked publications.
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 7 Oct 2015.