Tobacco Use CessationPhase 2NCT00124683
Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
A Phase 2 study testing Bupropion and nicotine transdermal patch in people with Tobacco Use Cessation and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA).
Trial summary
Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. 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 Cessation, Tobacco Use Disorder, Schizophrenia
- What is being tested?
- Bupropion and nicotine transdermal patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Sep 2001to May 2007
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence
- Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5
- Smokes at least 20 cigarettes per day (1 pack per day)
- Expired breath CO level > 10 ppm and cotinine level > 210 ng/ml at the baseline measurement
- Currently taking a stable dose of antipsychotic
- Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation
Who cannot join
- Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month
- History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)
- Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)
- Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)
- Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)
- History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)
About this study
Official title: Optimizing Treatment for Schizophrenic Smokers
Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.
Read the detailed description
Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking.
Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.
- Conditions
- Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia
- Being tested
- Bupropion, nicotine transdermal patch
- Keywords
- nicotine dependence
- Medical subject headings
- Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
nicotine transdermal patchDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nicotine Patch + Bupropion Receives: Drug: Bupropion; Drug: nicotine transdermal patch |
| 2 | Placebo comparator | Nicotine patch + placebo Receives: Drug: nicotine transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 day point prevalence of cigarette abstinence
Measured: End of trial (week 10)
Secondary outcomes (5)
Craving
Measured: assessed weekly
Medication compliance
Measured: assessed weekly
Depression
Measured: assessed at weeks 1, 4, 7, 10 and at six-month followup
Withdrawal symptoms
Measured: assessed weekly and at six month followup
Schizophrenic symptoms
Measured: assessed at weeks 1, 4, 7, 10 and at six-month followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startSep 2001
- Study completionMay 2007
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 CessationStudies 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Tony P George, M.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124683
- Sponsor's protocol ID
- NIDA-13672-1
- Other IDs
- R01-13672-1, DPMC
- Status last verified
- Aug 2007
- First submitted
- 26 Jul 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
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 37230961George TP, Vessicchio JC, Sacco KA, Weinberger AH, Dudas MM, Allen TM, Creeden CL, Potenza MN, Feingold A, Jatlow PI. A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. Biol Psychiatry. 2008 Jun 1;63(11):1092-6. doi: 10.1016/j.biopsych.2007.11.002. Epub 2007 Dec 21.
PubMed 18096137
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
- Optimizing Treatment for Schizophrenic Smokers
- ClinicalTrials.gov ID
- NCT00124683
- Acronym / sponsor ID
- NIDA-13672-1
- Conditions
- Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia
- Keywords
- nicotine dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Sep 2001
- Study completion
- May 2007 (actual)
- First posted
- 28 Jul 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.
Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.
Detailed description
Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking.
Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Bupropion, Drug: nicotine transdermal patchNicotine Patch + Bupropion |
| 2 | Placebo comparator | Drug: nicotine transdermal patchNicotine patch + placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence
- Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5
- Smokes at least 20 cigarettes per day (1 pack per day)
- Expired breath CO level > 10 ppm and cotinine level > 210 ng/ml at the baseline measurement
- Currently taking a stable dose of antipsychotic
Key exclusion criteria (6 listed)
- Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month
- History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP)
- Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus)
- Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin)
- Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations)
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 | Drug | 1 |
| nicotine transdermal patch | Drug | 1, 2 |
Primary outcome
7 day point prevalence of cigarette abstinence
Time frame: End of trial (week 10)
5 secondary outcomes
Craving
Time frame: assessed weekly
Medication compliance
Time frame: assessed weekly
Depression
Time frame: assessed at weeks 1, 4, 7, 10 and at six-month followup
Withdrawal symptoms
Time frame: assessed weekly and at six month followup
Schizophrenic symptoms
Time frame: assessed at weeks 1, 4, 7, 10 and at six-month followup
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.
- Derived from this study: PubMed 18096137George TP, Vessicchio JC, Sacco KA, Weinberger AH, Dudas MM, Allen TM, Creeden CL, Potenza MN, Feingold A, Jatlow PI. A placebo-controlled trial of bupropion combined with nicotine patch for smoking cessation in schizophrenia. Biol Psychiatry. 2008 Jun 1;63(11):1092-6. doi: 10.1016/j.biopsych.2007.11.002. Epub 2007 Dec 21.
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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.
Tony P George, M.D. principal investigator
Yale University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion and nicotine transdermal patch in people with Tobacco Use Cessation and Tobacco Use Disorder, run by National Institute on Drug Abuse (NIDA).
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 6 inclusion and 6 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.
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?
7 day point prevalence of cigarette abstinence (time frame: End of trial (week 10)). 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 NCT00124683, 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 12 Jan 2017.