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

ClinicalTrials.gov processed this record on October 23, 2014