Reduction of Smoking in Hospitalized Schizophrenia Patients - Full Text View

Sponsored by:	Lev-Hasharon Mental Healtlh Center
Information provided by:	Lev-Hasharon Mental Healtlh Center
ClinicalTrials.gov Identifier:	NCT00302432

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

MedlinePlus related topics: Schizophrenia Smoking

Drug Information available for: Amantadine Amantadine hydrochloride Amantadine sulfate Menthol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Effect of Cigarette Holders, Plastic Menthol Cigarettes, Amantadine Pharmacotherapy and Cognitive Behavioral Therapy for Smoking Reduction Among Schizophrenia Inpatients: A Comparative Study

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:

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.

Exclusion Criteria:

Significant physical illness.
Evidence of organic brain damage , mental retardation , alcohol or drug abuse.
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

Responsible Party:	Lev Hasharon Mental Health Center ( Dr. Rudinski )
Study ID Numbers:	LH16/2005.CTIL
Study First Received:	March 13, 2006
Last Updated:	June 10, 2008
ClinicalTrials.gov Identifier:	NCT00302432
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Lev-Hasharon Mental Healtlh Center:

smoking reduction
group therapy
cigarette holders
"Flowers Menthol"

Study placed in the following topic categories:

Schizophrenia
Smoking
Mental Disorders
Psychotic Disorders

Menthol
Amantadine
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Habits
Therapeutic Uses
Antipruritics
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009