The Effect of Cigarette Holders, Plastic Menthol Cigarettes, and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients: A Comparative Study

This study has been completed.
Sponsor:
Information provided by:
Lev-Hasharon Mental Healtlh Center
ClinicalTrials.gov Identifier:
NCT00302432
First received: March 13, 2006
Last updated: July 21, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Schizophrenia
Heavy Smoking
Behavioral: Behavior therapy, cigarette holders, Flowers Menthol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: The Effect of Cigarette Holders, Plastic Menthol Cigarettes, and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients: A Comparative Study

Resource links provided by NLM:


Further study details as provided by Lev-Hasharon Mental Healtlh Center:

Primary Outcome Measures:
  • Assessment of smoking dependence: [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • The Fagerstrom Tolerance Questionnaire for Nicotine Dependence (FTND) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Subjective Quality of Life: [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Quality of life enjoyment and satisfaction questionnaire -abbreviated version [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Rating Scales: [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) scale for psychosis [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Simpson Angus Scale for extrapyramidal side effects (SAS) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
  Hide Detailed Description

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:

  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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. Pregnant or nursing female patients.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302432

Locations
Israel
Lev-Hasharon MHC
Netanya, Israel, 42100
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr. Rudinski, Lev Hasharon Mental Health Center
ClinicalTrials.gov Identifier: NCT00302432     History of Changes
Other Study ID Numbers: LH16/2005.CTIL
Study First Received: March 13, 2006
Last Updated: July 21, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Lev-Hasharon Mental Healtlh Center:
smoking reduction
group therapy
cigarette holders
"Flowers Menthol"

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014