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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

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
History of Changes
  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:

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

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)
  Show Detailed Description

  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
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
Smoking
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Habits
 Menthol
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013