The Pharmacogenetic Study , Readiness to Change, and Pharmacological Intervention for Smoking Cessation in Schizophrenia (PSIAARP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00495352
Recruitment Status : Completed
First Posted : July 3, 2007
Last Update Posted : April 14, 2010
National Health Research Institutes, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Information provided by:
Yu-Li Hospital

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 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.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Schizophrenia Drug: Hihg-doseNRT, Low-dose NRT, bupropion Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : January 2006
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: High-dose NRT, Low-dose NRT, bupropion Drug: Hihg-doseNRT, Low-dose NRT, bupropion

Primary Outcome Measures :
  1. 7 day point prevalence of abstinence [ Time Frame: 8 weeks after the initiation of this trial ]

Secondary Outcome Measures :
  1. smoking reduction more than 50% and 25% [ Time Frame: 8 weeks after the initiation of this trial ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Competent volunteers completing consent form
  • Schizophreniform, schizoaffective,or psychotic disorder NOS based on DSMIV

Exclusion Criteria:

  • Severe life-threatening physical condition
  • Pregnancy
  • Fluroxamine treatment in the past 2 weeks
  • Allergy to nicotine or caffeine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00495352

Yuli hospital, DOH
Yuli Townhsip, Taiwan, 981
Sponsors and Collaborators
Yu-Li Hospital
National Health Research Institutes, Taiwan
Department of Health, Executive Yuan, R.O.C. (Taiwan)
Study Director: Tsuo-Hung Lan, MD, Ph.D General Clinical Research Center, YuLi hospital

Responsible Party: Yu-Li Hospital Identifier: NCT00495352     History of Changes
Other Study ID Numbers: MD-095-PP-05A
First Posted: July 3, 2007    Key Record Dates
Last Update Posted: April 14, 2010
Last Verified: April 2010

Keywords provided by Yu-Li Hospital:
Stages of change

Additional relevant MeSH terms:
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors