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

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ClinicalTrials.gov Identifier: NCT00302432
Recruitment Status : Completed
First Posted : March 14, 2006
Last Update Posted : July 22, 2010
Sponsor:
Information provided by:
Lev-Hasharon Mental Healtlh Center

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Heavy Smoking Behavioral: Behavior therapy, cigarette holders, Flowers Menthol Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : March 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol
U.S. FDA Resources




Primary Outcome Measures :
  1. Assessment of smoking dependence: [ Time Frame: 6 weeks ]
  2. The Fagerstrom Tolerance Questionnaire for Nicotine Dependence (FTND) [ Time Frame: 6 weeks ]
  3. 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 ]
  4. Subjective Quality of Life: [ Time Frame: 6 weeks ]
  5. Quality of life enjoyment and satisfaction questionnaire -abbreviated version [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Clinical Rating Scales: [ Time Frame: 6 weeks ]
  2. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 6 weeks ]
  3. Clinical Global Impression (CGI) scale for psychosis [ Time Frame: 6 weeks ]
  4. Hamilton Rating Scale for Depression (HAM-D) [ Time Frame: 6 weeks ]
  5. Simpson Angus Scale for extrapyramidal side effects (SAS) [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr. Rudinski, Lev Hasharon Mental Health Center
ClinicalTrials.gov Identifier: NCT00302432     History of Changes
Other Study ID Numbers: LH16/2005.CTIL
First Posted: March 14, 2006    Key Record Dates
Last Update Posted: July 22, 2010
Last Verified: July 2010

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

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Menthol
Antipruritics
Dermatologic Agents