The Effect of Cigarette Holders, Plastic Menthol Cigarettes, and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients: A Comparative Study
Condition: Schizophrenia; Heavy Smoking
MeSH terms: Schizophrenia
Study type: Interventional

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.
    

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      unpublished).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.
    

Intervention name(s): Behavior therapy, cigarette holders, Flowers Menthol
Intervention type(s): Behavioral
Intervention MeSH terms: Menthol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: smoking reduction; group therapy; cigarette holders; "Flowers Menthol"