Nicotine DependencePhase 4NCT01576640
Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
A Phase 4 study testing NRT, Bupropion SR 150mg bid and Relapse Prevention-Oriented Cognitive Behavioral Therapy in people with Nicotine Dependence and Schizophrenia, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Schizophrenia
- What is being tested?
- NRT, Bupropion SR 150mg bid and Relapse Prevention-Oriented Cognitive Behavioral Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Oct 2007
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
- Reported smoking 10 or more cigarettes per day for at least the prior year
- Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
- Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
- Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment
Who cannot join
- Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.
Trial locations and contacts
1 site in 1 country.
United States1 site
Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street
Boston, Massachusetts, 02114
About this study
Official title: An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia
After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.
- Conditions
- Nicotine Dependence, Schizophrenia
- Being tested
- NRT, Bupropion SR 150mg bid, Relapse Prevention-Oriented Cognitive Behavioral Therapy
- Keywords
- Nicotine Dependence, Smoking Cessation, Relapse Prevention, Cognitive Behavioral Therapy, Schizophrenia
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRTDrug
Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch
Bupropion SR 150mg bidDrug
Subjects were given bupropion SR 150 mg bid throughout the course of the study.
Relapse Prevention-Oriented Cognitive Behavioral TherapyOther
Subjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Replapse Prevention Therapy | Other | Not described Receives: Drug: NRT; Drug: Bupropion SR 150mg bid; Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-Day Point Prevalence Abstinence at Month 15
Secondary outcomes (1)
4-Week Continuous Abstinence at Month 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startDec 2005
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, A. Eden Evins, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01576640
- Sponsor's protocol ID
- P2008-04
- Status last verified
- May 2015
- First submitted
- 10 Apr 2012
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT01576640
- Acronym / sponsor ID
- P2008-04
- Conditions
- Nicotine Dependence, Schizophrenia
- Keywords
- Nicotine Dependence, Smoking Cessation, Relapse Prevention, Cognitive Behavioral Therapy, Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 12 Apr 2012 (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.
After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Replapse Prevention Therapy | Other | Drug: NRT, Drug: Bupropion SR 150mg bid, Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
- Reported smoking 10 or more cigarettes per day for at least the prior year
- Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
- Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
- Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment
Key exclusion criteria (1 listed)
- Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.
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 |
|---|---|---|
| NRTParticipants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch | Drug | Replapse Prevention Therapy |
| Bupropion SR 150mg bidSubjects were given bupropion SR 150 mg bid throughout the course of the study. | Drug | Replapse Prevention Therapy |
| Relapse Prevention-Oriented Cognitive Behavioral TherapySubjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks. | Other | Replapse Prevention Therapy |
Primary outcome
7-Day Point Prevalence Abstinence at Month 15
1 secondary outcome
4-Week Continuous Abstinence at Month 15
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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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 NRT, Bupropion SR 150mg bid and Relapse Prevention-Oriented Cognitive Behavioral Therapy in people with Nicotine Dependence and Schizophrenia, run by Massachusetts General Hospital 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 5 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: stopped early, as of the sponsor's last update on 21 May 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. 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 was stopped early. Results are not available in the source record.
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?
7-Day Point Prevalence Abstinence at Month 15. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2015.