Tobacco DependencePhase 4PSIAARPNCT00495352
The Pharmacogenetic Study , Readiness to Change, and Pharmacological Intervention for Smoking Cessation in Schizophrenia
A Phase 4 study testing Hihg-doseNRT, Low-dose NRT, bupropion in people with Tobacco Dependence and Schizophrenia, run by Yu-Li Hospital at 1 site in Taiwan.
Trial summary
Cigarette smoking represents a major health problem for patients suffering from schizophrenia. Compared to the general population, schizophrenic patients are significantly more likely to be addicted to nicotine. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Tobacco Dependence, Schizophrenia
- What is being tested?
- Hihg-doseNRT, Low-dose NRT, bupropion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2006to Dec 2008
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Competent volunteers completing consent form
- Schizophreniform, schizoaffective,or psychotic disorder NOS based on DSMIV
Who cannot join
- Severe life-threatening physical condition
- Pregnancy
- Fluroxamine treatment in the past 2 weeks
- Allergy to nicotine or caffeine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 1. The Pharmacogenetic Study of Interaction Among Antipsychotics, Readiness to Change, and Pharmacological Intervention for Smoking Cessation Among Schizophrenic Patients 2. Stages of Change and Outcomes of Nicotine Replacement Therapy in Chronic Schizophrenic Patients
Cigarette smoking represents a major health problem for patients suffering from schizophrenia. Compared to the general population, schizophrenic patients are significantly more likely to be addicted to nicotine. They also are more likely to be heavy smokers, and tend to be exposed disproportionately to nicotine and other harmful ingredients in the cigarette because of the observed tendency to smoke down to the very end. Further, smoking in these patients may be associated with a higher risk for developing tardive dyskinesia All of these factors render schizophrenic patients a particularly vulnerable group for the detrimental effects of tobacco-related medical problems. Currently, there is little information available regarding the efficacy and utility of smoking cessation treatment methods, as well as factors that may predict patients' response to such treatments.
An important related issue is the influence of smoking, and its cessation, on the effects of the medications most of these patients rely upon for the control of their psychiatric symptoms. Although smoking has long been known to significantly alter the metabolism, and thus the effects, of most antipsychotics, the extent and clinical significance of these influences have rarely been assessed. It is unclear to what extent smoke cessation (as well as initiation) changes the side effect profiles of these medications, and whether such changes contribute towards the difficulties in patients' ability and/or willingness to stop smoking.
Read more
In addition, except pharmacological intervention, readiness to change may be an important factor affecting the outcomes of smoking reduction. Prochaska et al proposed the concept of stages of change to predict the response of quitting behavior for substance use. A lot of evidence support the stronger of readiness of change, the higher successful rate of quitting can be reached. Yet these results are largely found in many non-pharmacological intervention and smoking cessation programs for general population. Till now, no available study solely focus readiness of change quitting smoking behavior in NRT treatment for chronic schizophrenic patients. Thus, we have an a great interest in examining the association between the stages of change and the outcomes of smoking-cessation along with reduction among schizophrenic patients receiving transdermal nicotine patches.
In order to begin addressing these important issues, this application proposes to utilize state-of-the-art methodologies derived from the field of pharmacogenetics, molecular biology and clinical trials, to (1) examine short-term and long-term efficacy of standard treatment methods, such as the use of nicotine patches, in this population; (2) identify factors that might predict treatment responses; and, (3) examine the interactions between smoking and the effect of antipsychotics, as well as how such interactions might affect smoking cessation. (4) to examine the predictive value of the stages of change on smoking cessation and reduction outcomes in schizophrenic patients receiving different doses of nicotine replacement therapy (NRT) and bupropion as implemented in a randomized trial.
Read the detailed description
Specific Aims
Accordingly, this proposal aims at testing the following major hypotheses:
- Nicotine patch therapy and bupropion are effective in smoke cessation among motivated psychiatric outpatients with schizophrenia.
1a. High dose nicotine patch therapy is significantly more effective in inducing smoke cessation than regular dose nicotine patch therapy.
1b. Nicotine patch therapy and bupropion are more effective in inducing smoke cessation in those treated with "atypical" neuroleptics as compared to those treated with "typical" neuroleptics.
- Response to nicotine patch therapy is associated with genetic polymorphisms of DRD2, dopamine transporter (DAT; SLC6A3), CYP2A6 and CYP2D6 genes.
- Smoke cessation is associated with a significant decrease in the activity of CYP1A2, as well as a significant increase in the steady-state concentration of the neuroleptics received by the patients. This will lead to an increased incidence of treatment emergent side effects, which may be controlled by neuroleptic dose adjustment.
- patients in the stage of preparation or contemplation (stronger readiness to quit smoking) are more likely to reduce smoking and stop smoking than those in the stage of precontemplation (weaker readiness to quitting smoking).
- Conditions
- Tobacco Dependence, Schizophrenia
- Being tested
- Hihg-doseNRT, Low-dose NRT, bupropion
- Keywords
- Schizophrenia, NRT, Bupropion, Stages of change
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hihg-doseNRT, Low-dose NRT, bupropionDrug
| Study group | Role | What they receive |
|---|---|---|
| High-dose NRT, Low-dose NRT, bupropion | Active comparator | Not described Receives: Drug: Hihg-doseNRT, Low-dose NRT, bupropion |
What is being measured
The primary outcome is the main question the study is designed to answer.
7 day point prevalence of abstinence
Measured: 8 weeks after the initiation of this trial
Secondary outcomes (1)
smoking reduction more than 50% and 25%
Measured: 8 weeks after the initiation of this trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2007 (estimated)
- Study startJan 2006
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies 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
- Double blind
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yu-Li Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Investigators
- Tsuo-Hung Lan, MD, Ph.D, Study director, General Clinical Research Center, YuLi hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00495352
- Sponsor's protocol ID
- MD-095-PP-05A
- Acronym
- PSIAARP
- Status last verified
- Apr 2010
- First submitted
- 30 Jun 2007
- Last updated
- 14 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1. The Pharmacogenetic Study of Interaction Among Antipsychotics, Readiness to Change, and Pharmacological Intervention for Smoking Cessation Among Schizophrenic Patients 2. Stages of Change and Outcomes of Nicotine Replacement Therapy in Chronic Schizophrenic Patients
- ClinicalTrials.gov ID
- NCT00495352
- Acronym / sponsor ID
- PSIAARP / MD-095-PP-05A
- Conditions
- Tobacco Dependence, Schizophrenia
- Keywords
- Schizophrenia, NRT, Bupropion, Stages of change
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Yu-Li HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan, Department of Health, Executive Yuan, R.O.C. (Taiwan)
- Study start
- Jan 2006
- Study completion
- Dec 2008 (actual)
- First posted
- 3 Jul 2007 (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.
Cigarette smoking represents a major health problem for patients suffering from schizophrenia. Compared to the general population, schizophrenic patients are significantly more likely to be addicted to nicotine. They also are more likely to be heavy smokers, and tend to be exposed disproportionately to nicotine and other harmful ingredients in the cigarette because of the observed tendency to smoke down to the very end. Further, smoking in these patients may be associated with a higher risk for developing tardive dyskinesia All of these factors render schizophrenic patients a particularly vulnerable group for the detrimental effects of tobacco-related medical problems. Currently, there is little information available regarding the efficacy and utility of smoking cessation treatment methods, as well as factors that may predict patients' response to such treatments.
An important related issue is the influence of smoking, and its cessation, on the effects of the medications most of these patients rely upon for the control of their psychiatric symptoms. Although smoking has long been known to significantly alter the metabolism, and thus the effects, of most antipsychotics, the extent and clinical significance of these influences have rarely been assessed. It is unclear to what extent smoke cessation (as well as initiation) changes the side effect profiles of these medications, and whether such changes contribute towards the difficulties in patients' ability and/or willingness to stop smoking.
In addition, except pharmacological intervention, readiness to change may be an important factor affecting the outcomes of smoking reduction. Prochaska et al proposed the concept of stages of change to predict the response of quitting behavior for substance use. A lot of evidence support the stronger of readiness of change, the higher successful rate of quitting can be reached. Yet these results are largely found in many non-pharmacological intervention and smoking cessation programs for general population. Till now, no available study solely focus readiness of change quitting smoking behavior in NRT treatment for chronic schizophrenic patients. Thus, we have an a great interest in examining the association between the stages of change and the outcomes of smoking-cessation along with reduction among schizophrenic patients receiving transdermal nicotine patches.
In order to begin addressing these important issues, this application proposes to utilize state-of-the-art methodologies derived from the field of pharmacogenetics, molecular biology and clinical trials, to (1) examine short-term and long-term efficacy of standard treatment methods, such as the use of nicotine patches, in this population; (2) identify factors that might predict treatment responses; and, (3) examine the interactions between smoking and the effect of antipsychotics, as well as how such interactions might affect smoking cessation. (4) to examine the predictive value of the stages of change on smoking cessation and reduction outcomes in schizophrenic patients receiving different doses of nicotine replacement therapy (NRT) and bupropion as implemented in a randomized trial.
Detailed description
Specific Aims
Accordingly, this proposal aims at testing the following major hypotheses:
- Nicotine patch therapy and bupropion are effective in smoke cessation among motivated psychiatric outpatients with schizophrenia.
1a. High dose nicotine patch therapy is significantly more effective in inducing smoke cessation than regular dose nicotine patch therapy.
1b. Nicotine patch therapy and bupropion are more effective in inducing smoke cessation in those treated with "atypical" neuroleptics as compared to those treated with "typical" neuroleptics.
- Response to nicotine patch therapy is associated with genetic polymorphisms of DRD2, dopamine transporter (DAT; SLC6A3), CYP2A6 and CYP2D6 genes.
- Smoke cessation is associated with a significant decrease in the activity of CYP1A2, as well as a significant increase in the steady-state concentration of the neuroleptics received by the patients. This will lead to an increased incidence of treatment emergent side effects, which may be controlled by neuroleptic dose adjustment.
- patients in the stage of preparation or contemplation (stronger readiness to quit smoking) are more likely to reduce smoking and stop smoking than those in the stage of precontemplation (weaker readiness to quitting smoking).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-dose NRT, Low-dose NRT, bupropion | Active comparator | Drug: Hihg-doseNRT, Low-dose NRT, bupropion |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Competent volunteers completing consent form
- Schizophreniform, schizoaffective,or psychotic disorder NOS based on DSMIV
Key exclusion criteria (4 listed)
- Severe life-threatening physical condition
- Pregnancy
- Fluroxamine treatment in the past 2 weeks
- Allergy to nicotine or caffeine
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 |
|---|---|---|
| Hihg-doseNRT, Low-dose NRT, bupropion | Drug | High-dose NRT, Low-dose NRT, bupropion |
Primary outcome
7 day point prevalence of abstinence
Time frame: 8 weeks after the initiation of this trial
1 secondary outcome
smoking reduction more than 50% and 25%
Time frame: 8 weeks after the initiation of this trial
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 14 Apr 2010.
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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.
Tsuo-Hung Lan, MD, Ph.D study director
General Clinical Research Center, YuLi 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 Hihg-doseNRT, Low-dose NRT, bupropion in people with Tobacco Dependence and Schizophrenia, run by Yu-Li Hospital at 1 site in Taiwan.
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 2 inclusion and 4 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 14 Apr 2010. 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 Taiwan. 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 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 abstinence (time frame: 8 weeks after the initiation of this trial). 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 14 Apr 2010.