Tobacco-Use DisorderPhase 4NCT00307203
Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke
A Phase 4 study testing bupropion SR, Cognitive Behavioral Group Therapy and nicotine replacement therapy in people with Tobacco-Use Disorder and Schizophrenia, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco-Use Disorder, Schizophrenia, Psychotic Disorders
- What is being tested?
- bupropion SR, Cognitive Behavioral Group Therapy and nicotine replacement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 1998to Feb 2004
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
- Smokes at least 10 cigarettes per day
- Wishes to stop smoking
- Attended last three scheduled clinic visits, prior to study entry
Who cannot join
- Significant medical or neurologic illness
- History of severe head injury with loss of consciousness
- Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
- Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
- Currently undergoing an acute exacerbation of psychotic symptoms
- Current or history of bulimia or anorexia
Show all 12Show fewer
- Current excessive water intake
- Recent history of mania
- Known allergy or hypersensitivity to bupropion
- Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco
- Currently receiving treatment with bupropion
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nicotine and Smoking Cessation in Schizophrenia
Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.
Read the detailed description
Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74 and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected public health problem for people with schizophrenia; smoking cessation treatment is often overlooked as part of the psychiatric care for such individuals.
The most effective treatment for smoking cessation described to date is sustained release (SR) bupropion. Past research suggests that SR bupropion may be especially effective in individuals with depressive symptoms, including individuals with schizophrenia. The purpose of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with cognitive behavioral therapy (CBT), in individuals with schizophrenia.
This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion or placebo. All participants will receive weekly CBT. Participants will be followed for 3 months following completion of the 12-week treatment session.
- Conditions
- Tobacco-Use Disorder, Schizophrenia, Psychotic Disorders
- Being tested
- bupropion SR, Cognitive Behavioral Group Therapy, nicotine replacement therapy
- Keywords
- Bupropion, Zyban, Wellbutrin, Smoking cessation, Schizophrenia, Schizoaffective disorder, Cognitive Behavioral Therapy
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia, Psychotic Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupropion SRDrug
Also called Zyban, Wellbutrin
Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
Cognitive Behavioral Group TherapyBehavioural
Also called CBT
Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
nicotine replacement therapyDrug
Also called nicotine patch; nicotine gum
Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy Receives: Drug: bupropion SR; Behavioral: Cognitive Behavioral Group Therapy; Drug: nicotine replacement therapy |
| II | Placebo comparator | Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy Receives: Behavioral: Cognitive Behavioral Group Therapy; Drug: nicotine replacement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
Measured: end of treatment
Secondary outcomes (8)
continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
Measured: end of treatment
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
Measured: end of treatment
psychotic symptoms
Measured: continuous and end of treatment
negative side effects
Measured: continuous
negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases
Measured: continuous and end of treatment
measures of attention and memory while attempting to quit smoking
Measured: end of treatment
health-related quality at the end of the 3-month treatment and 3-month follow-up phases
Measured: continuous and end of treatment
weight gain at the end of the 3-month treatment and 3-month follow-up phases
Measured: continuous and end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2006 (estimated)
- Study startAug 1998
- Primary completionFeb 2004
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco-Use DisorderStudies 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
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- A Eden Evins, MD, MPH, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00307203
- Sponsor's protocol ID
- K23DA000510
- Other IDs
- DPMC
- Status last verified
- Sep 2008
- First submitted
- 23 Mar 2006
- Last updated
- 11 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6. doi: 10.1097/01.jcp.0b013e3180ca86fa.
PubMed 17632223Hajizadeh 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 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine and Smoking Cessation in Schizophrenia
- ClinicalTrials.gov ID
- NCT00307203
- Acronym / sponsor ID
- K23DA000510
- Conditions
- Tobacco-Use Disorder, Schizophrenia, Psychotic Disorders
- Keywords
- Bupropion, Zyban, Wellbutrin, Smoking cessation, Schizophrenia, Schizoaffective disorder, Cognitive Behavioral Therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Aug 1998
- Primary completion
- Feb 2004 (actual)
- Study completion
- Feb 2004 (actual)
- First posted
- 27 Mar 2006 (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. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.
Detailed description
Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74 and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected public health problem for people with schizophrenia; smoking cessation treatment is often overlooked as part of the psychiatric care for such individuals.
The most effective treatment for smoking cessation described to date is sustained release (SR) bupropion. Past research suggests that SR bupropion may be especially effective in individuals with depressive symptoms, including individuals with schizophrenia. The purpose of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with cognitive behavioral therapy (CBT), in individuals with schizophrenia.
This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion or placebo. All participants will receive weekly CBT. Participants will be followed for 3 months following completion of the 12-week treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Drug: bupropion SR, Behavioral: Cognitive Behavioral Group Therapy, Drug: nicotine replacement therapyExperiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy |
| II | Placebo comparator | Behavioral: Cognitive Behavioral Group Therapy, Drug: nicotine replacement therapyPlacebo group received placebo, in addition to weekly CBT and nicotine replacement therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
- Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
- Smokes at least 10 cigarettes per day
- Wishes to stop smoking
- Attended last three scheduled clinic visits, prior to study entry
Key exclusion criteria (12 listed)
- Significant medical or neurologic illness
- History of severe head injury with loss of consciousness
- Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
- Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
- Currently undergoing an acute exacerbation of psychotic symptoms
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 SRAlso: Zyban, WellbutrinParticipants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks. | Drug | I |
| Cognitive Behavioral Group TherapyAlso: CBTParticipants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week. | Behavioural | I, II |
| nicotine replacement therapyAlso: nicotine patch; nicotine gumNicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d. | Drug | I, II |
Primary outcome
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
Time frame: end of treatment
8 secondary outcomes
continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
Time frame: end of treatment
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
Time frame: end of treatment
psychotic symptoms
Time frame: continuous and end of treatment
negative side effects
Time frame: continuous
negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases
Time frame: continuous and end of treatment
measures of attention and memory while attempting to quit smoking
Time frame: end of treatment
health-related quality at the end of the 3-month treatment and 3-month follow-up phases
Time frame: continuous and end of treatment
weight gain at the end of the 3-month treatment and 3-month follow-up phases
Time frame: continuous and end of treatment
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 11 Jan 2017.
- Results publication: PubMed 17632223Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6. doi: 10.1097/01.jcp.0b013e3180ca86fa.
- 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.
A Eden Evins, MD, MPH principal investigator
Massachusetts General Hospital
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 SR, Cognitive Behavioral Group Therapy and nicotine replacement therapy in people with Tobacco-Use Disorder and Schizophrenia, run by National Institute on Drug Abuse (NIDA) 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 12 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 11 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 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 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.
What does the primary outcome measure?
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline (time frame: end of treatment). 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 NCT00307203, 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 11 Jan 2017.