Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00495352
Status:
COMPLETED
Last Update Posted:
2010-04-14
First Post:
2007-06-30
Brief Title:
The Pharmacogenetic Study Readiness to Change and Pharmacological Intervention for Smoking Cessation in Schizophrenia
Sponsor:
Yu-Li Hospital
Organization:
Yu-Li Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PSIAARP
Brief 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 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 andor 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
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 andor 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
1 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
2 Response to nicotine patch therapy is associated with genetic polymorphisms of DRD2 dopamine transporter DAT SLC6A3 CYP2A6 and CYP2D6 genes
3 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
4 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
Accordingly this proposal aims at testing the following major hypotheses
1 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
2 Response to nicotine patch therapy is associated with genetic polymorphisms of DRD2 dopamine transporter DAT SLC6A3 CYP2A6 and CYP2D6 genes
3 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
4 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None