Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00302432
Status:
COMPLETED
Last Update Posted:
2010-07-22
First Post:
2006-03-13
Brief Title:
The Effect of Cigarette Holders Plastic Menthol Cigarettes and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients A Comparative Study
Sponsor:
Lev-Hasharon Mental Healtlh Center
Organization:
Lev-Hasharon Mental Healtlh Center
Study Overview
Official Title:
The Effect of Cigarette Holders Plastic Menthol Cigarettes and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients A Comparative Study
Status:
COMPLETED
Status Verified Date:
2010-07
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:
None
Brief Summary:
This study aims
1 to assess the effect of smoking reduction programs behavior therapy alone or behavior therapy with cigarette holders Flowers Menthol plastic cigarettes with menthol on cigarette smoking habits in an antipsychotic treated schizophrenia population
1 to assess the effect of smoking reduction programs behavior therapy alone or behavior therapy with cigarette holders Flowers Menthol plastic cigarettes with menthol on cigarette smoking habits in an antipsychotic treated schizophrenia population
Detailed Description:
Smoking is a leading preventable cause of death in the western world The highest incidence of smoking is among psychiatric inpatients The issue of smoking among psychiatric patients needs to be addressed since this population already suffers from physical comorbidity and reduced life expectancy Brown et al 2000 which increase with smoking considering the additional risk factors for cardiovascular diseases obesity high cholesterol diabetes In addition the increased risk factors associated with second generation antipsychotic treatment need to be considered Significant financial expenditures for the purchase of cigarettes from an already extremely limited budget Steinberg et al 2004 should be taken into account Psychiatric patients who smoke spend up to 30 of their welfare payments on cigarettes
A survey performed in our mental health center revealed that over 30 of the patients who smoke are interested in specific treatment to reducestop smoking Melamed et al unpublished Our survey found that The expressed desire of the patients to quit smoking and the known dangers of smoking especially in this population reflect the importance of integrating smoking reductioncessation programs into the treatment regimens of psychiatric inpatients
Treatment options to promote smoking cessation include hypnosis Spiegel et la 1993 Weizman et al 2004 behavior therapy Addington et al 1998 group therapy Addington 1998 nicotine replacement therapies NRT Fant et al 2000 and pharmacotherapy such as bupropion George et al 2002
Since it is recommended that many smoking cessation treatment options such as NRT nicotine transdermal patches or nicotine polacrilex gum nasal spray cigarette filters and nicotine inhalers should not be used together with actual nicotine intake we decided to gradually introduce the issue of smoking reductioncessation to the inpatient population by initially introducing a program for smoking reduction
Smoking reduction options include
1 Cigarette holders
2 Flowers Menthol
3 Behavior therapy including various relaxation techniques
Methods Study population 60 subjects will be drawn from the inpatient population of Lev-Hasharon Mental Health Center and divided into 4 groups of 15 participants each
Inclusion criteria
1 Age 18-65 male or female
2 DSM -IV criteria for chronic schizophrenia or schizoaffective disorder
3 Ability and willingness to sign informed consent for participation in the study
4 Patients expressed interest in participating in a smoking-reduction program
5 Smoking a minimum of 20 cigarettes daily for 6 months prior to the study period as per patient report
6 Patients treated with antipsychotic agents Exclusion criteria
1- Significant physical illness 2- Evidence of organic brain damage mental retardation alcohol or drug abuse
3- Contraindication to amantadine treatment 4- Pregnant or nursing female patients
Duration of study will be 6 weeks Patients will be assigned to one of 4 the intervention groups Group assignment will be according to the department where the patient is hospitalized
Group 1 - Behavior therapy only Group 2 - Behavior therapy with cigarette holders Group 3 - Behavior therapy with Flowers Menthol There will be no restrictions regarding the type of antipsychotic medication typical or atypical that participants are currently treated with
Proposed study duration is 6 weeks All patients will participate in 5 weekly behavioral group therapy sessions for smoking reduction Each department will have a staff member devoted to smoking reduction smoking supervisors who will accompany the patients throughout the week advising counseling and supporting during crises
Group 1 will have behavioral group therapy for smoking reduction with not additional intervention
Group 2 will be administered plastic cigarette holders The nursing staff will distribute the holders one at a time Used holders will be returned to the smoking supervisor when the sieve is blocked usually after five cigarettes
Group 3 will be administered Flowers Menthol smokeless inhalers one per day by the smoking supervisor Used devices will be returned to himher
After receiving a detailed explanation of study procedures patients will sign informed consent Throughout the study period cigarettes will be distributed freely Participants will fill out tables recording the number of cigarettes smoked with the help of their smoking supervisors
Instruments
Patients will be assessed at baseline and end of week 6 with the following instruments
Clinical Rating Scales The patients mental condition will be assessed with the Positive and Negative Syndrome Scale PANSS Kay et al 1987 Clinical Global Impression CGI scale for psychosis Guy1976 Hamilton Rating Scale for Depression HAM-D Hamilton1960 Simpson Angus Scale for extrapyramidal side effects SAS Simpson and Angus 1970 Assessment of smoking dependence The Fagerstrom Tolerance Questionnaire for Nicotine Dependence FTND Fagerstrom KO 1978 is useful and simple to administer for the evaluation of nicotine dependence
Weekly table for self-report of the number of cigarettes smoked will be filled out by participants with the help of the smoking supervisors
Subjective Quality of Life Quality of life enjoyment and satisfaction questionnaire -abbreviated version Q-LES-Q-18 Ritsner et al 2005
Statistical analysis Appropriate statistical analysis will be performed including ANOVA with repeated measures
A survey performed in our mental health center revealed that over 30 of the patients who smoke are interested in specific treatment to reducestop smoking Melamed et al unpublished Our survey found that The expressed desire of the patients to quit smoking and the known dangers of smoking especially in this population reflect the importance of integrating smoking reductioncessation programs into the treatment regimens of psychiatric inpatients
Treatment options to promote smoking cessation include hypnosis Spiegel et la 1993 Weizman et al 2004 behavior therapy Addington et al 1998 group therapy Addington 1998 nicotine replacement therapies NRT Fant et al 2000 and pharmacotherapy such as bupropion George et al 2002
Since it is recommended that many smoking cessation treatment options such as NRT nicotine transdermal patches or nicotine polacrilex gum nasal spray cigarette filters and nicotine inhalers should not be used together with actual nicotine intake we decided to gradually introduce the issue of smoking reductioncessation to the inpatient population by initially introducing a program for smoking reduction
Smoking reduction options include
1 Cigarette holders
2 Flowers Menthol
3 Behavior therapy including various relaxation techniques
Methods Study population 60 subjects will be drawn from the inpatient population of Lev-Hasharon Mental Health Center and divided into 4 groups of 15 participants each
Inclusion criteria
1 Age 18-65 male or female
2 DSM -IV criteria for chronic schizophrenia or schizoaffective disorder
3 Ability and willingness to sign informed consent for participation in the study
4 Patients expressed interest in participating in a smoking-reduction program
5 Smoking a minimum of 20 cigarettes daily for 6 months prior to the study period as per patient report
6 Patients treated with antipsychotic agents Exclusion criteria
1- Significant physical illness 2- Evidence of organic brain damage mental retardation alcohol or drug abuse
3- Contraindication to amantadine treatment 4- Pregnant or nursing female patients
Duration of study will be 6 weeks Patients will be assigned to one of 4 the intervention groups Group assignment will be according to the department where the patient is hospitalized
Group 1 - Behavior therapy only Group 2 - Behavior therapy with cigarette holders Group 3 - Behavior therapy with Flowers Menthol There will be no restrictions regarding the type of antipsychotic medication typical or atypical that participants are currently treated with
Proposed study duration is 6 weeks All patients will participate in 5 weekly behavioral group therapy sessions for smoking reduction Each department will have a staff member devoted to smoking reduction smoking supervisors who will accompany the patients throughout the week advising counseling and supporting during crises
Group 1 will have behavioral group therapy for smoking reduction with not additional intervention
Group 2 will be administered plastic cigarette holders The nursing staff will distribute the holders one at a time Used holders will be returned to the smoking supervisor when the sieve is blocked usually after five cigarettes
Group 3 will be administered Flowers Menthol smokeless inhalers one per day by the smoking supervisor Used devices will be returned to himher
After receiving a detailed explanation of study procedures patients will sign informed consent Throughout the study period cigarettes will be distributed freely Participants will fill out tables recording the number of cigarettes smoked with the help of their smoking supervisors
Instruments
Patients will be assessed at baseline and end of week 6 with the following instruments
Clinical Rating Scales The patients mental condition will be assessed with the Positive and Negative Syndrome Scale PANSS Kay et al 1987 Clinical Global Impression CGI scale for psychosis Guy1976 Hamilton Rating Scale for Depression HAM-D Hamilton1960 Simpson Angus Scale for extrapyramidal side effects SAS Simpson and Angus 1970 Assessment of smoking dependence The Fagerstrom Tolerance Questionnaire for Nicotine Dependence FTND Fagerstrom KO 1978 is useful and simple to administer for the evaluation of nicotine dependence
Weekly table for self-report of the number of cigarettes smoked will be filled out by participants with the help of the smoking supervisors
Subjective Quality of Life Quality of life enjoyment and satisfaction questionnaire -abbreviated version Q-LES-Q-18 Ritsner et al 2005
Statistical analysis Appropriate statistical analysis will be performed including ANOVA with repeated measures
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