Behavior therapy, cigarette holders, Flowers Menthol in Schizophrenia and Heavy Smoking - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Behavioral: Behavior therapy, cigarette holders, Flowers Menthol

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that over 30% of the patients who smoke are interested in specific treatment to reduce/stop smoking (Melamed et al., unpublished).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 reduction/cessation 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 reduction/cessation to the inpatient population, by initially introducing a program for smoking reduction.

Smoking reduction options include:

Cigarette holders
"Flowers Menthol"
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

Age 18-65 male or female.
DSM -IV criteria for chronic schizophrenia or schizoaffective disorder.
Ability and willingness to sign informed consent for participation in the study.
Patients' expressed interest in participating in a smoking-reduction program
Smoking a minimum of 20 cigarettes daily, for 6 months prior to the study period, as per patient report.
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 him/her.

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 (Guy,1976), Hamilton Rating Scale for Depression (HAM-D) (Hamilton,1960), 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 Type

Interventional

Enrollment (Actual)

37

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Netanya, Israel, 42100
    - Lev-Hasharon MHC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 18-65 male or female.
DSM -IV criteria for chronic schizophrenia or schizoaffective disorder.
Ability and willingness to sign informed consent for participation in the study.
Patients' expressed interest in participating in a smoking-reduction program
Smoking a minimum of 20 cigarettes daily, for 6 months prior to the study period, as per patient report.
Patients treated with antipsychotic agents.

Exclusion Criteria:

Significant physical illness.
Evidence of organic brain damage , mental retardation , alcohol or drug abuse.
Pregnant or nursing female patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of smoking dependence: Time Frame: 6 weeks	6 weeks
The Fagerstrom Tolerance Questionnaire for Nicotine Dependence (FTND) Time Frame: 6 weeks	6 weeks
Weekly table for self-report of the number of cigarettes smoked will be filled out by participants with the help of the "smoking supervisors". Time Frame: 6 weeks	6 weeks
Subjective Quality of Life: Time Frame: 6 weeks	6 weeks
Quality of life enjoyment and satisfaction questionnaire -abbreviated version Time Frame: 6 weeks	6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical Rating Scales: Time Frame: 6 weeks	6 weeks
Positive and Negative Syndrome Scale (PANSS) Time Frame: 6 weeks	6 weeks
Clinical Global Impression (CGI) scale for psychosis Time Frame: 6 weeks	6 weeks
Hamilton Rating Scale for Depression (HAM-D) Time Frame: 6 weeks	6 weeks
Simpson Angus Scale for extrapyramidal side effects (SAS) Time Frame: 6 weeks	6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lev-Hasharon Mental Healtlh Center

Investigators

Principal Investigator: Dmitri Rudinski, MD, Lev-Hasharon MHC
Study Director: Yuval Melamed, MD, MHA, Lev-Hasharon MHC
Study Chair: Olga Preisman, MD, Lev-Hasharon MHC
Study Chair: Deby Peres, MD, Lev-Hasharon.MHC
Study Chair: Marc Gelkopf, Phd, Lev-Hasharon MHC
Study Chair: Sigalit Noam, RN, BA, Lev-Hasharon MHC
Study Chair: Arturo Lerner, MD, Lev-Hasharon MHC
Study Director: Avi Bleich, MD, MPH, Lev-Hasharon MHC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 13, 2006

First Submitted That Met QC Criteria