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

NCT00302432 | Completed

• 1 other identifier: LH16/2005.CTIL
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Heavy Smoking

Keywords

smoking reduction; group therapy; cigarette holders; "Flowers Menthol"

Outcome Measures

Primary Outcomes (5)

• Assessment of smoking dependence:

  6 weeks

• The Fagerstrom Tolerance Questionnaire for Nicotine Dependence (FTND)

  6 weeks

• Weekly table for self-report of the number of cigarettes smoked will be filled out by participants with the help of the "smoking supervisors".

  6 weeks

• Subjective Quality of Life:

  6 weeks

• Quality of life enjoyment and satisfaction questionnaire -abbreviated version

  6 weeks

Secondary Outcomes (5)

• Clinical Rating Scales:

  6 weeks

• Positive and Negative Syndrome Scale (PANSS)

  6 weeks

• Clinical Global Impression (CGI) scale for psychosis

  6 weeks

• Hamilton Rating Scale for Depression (HAM-D)

  6 weeks

• Simpson Angus Scale for extrapyramidal side effects (SAS)

  6 weeks

Interventions

Behavior therapy, cigarette holders, Flowers Menthol BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 male or female.
• DSM -IV criteria for chronic schizophrenia or schizoaffective disorder.
• Ability and willingness to sign informed consent for participation in the study.
• Patients' expressed interest in participating in a smoking-reduction program
• Smoking a minimum of 20 cigarettes daily, for 6 months prior to the study period, as per patient report.
• Patients treated with antipsychotic agents.

You may not qualify if:

• Significant physical illness.
• Evidence of organic brain damage , mental retardation , alcohol or drug abuse.
• Pregnant or nursing female patients.

Sponsors & Collaborators

• Lev-Hasharon Mental Healtlh Center: lead

Study Sites (1)

Lev-Hasharon MHC

Netanya, 42100, Israel

Location

MeSH Terms

Conditions

Schizophrenia; Smoking Reduction

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dmitri Rudinski, MD

  Lev-Hasharon MHC

  PRINCIPAL INVESTIGATOR

• Yuval Melamed, MD, MHA

  Lev-Hasharon MHC

  STUDY DIRECTOR

• 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 CHAIR

• Avi Bleich, MD, MPH

  Lev-Hasharon MHC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 14, 2006
• Study Start: March 1, 2006
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: July 22, 2010

Record last verified: 2010-07

Locations

IL (1)