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Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse (SCHIZOCAN)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00798109
First Posted: November 25, 2008
Last Update Posted: June 16, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
September 30, 2008
November 25, 2008
June 16, 2014
November 2008
October 2012   (Final data collection date for primary outcome measure)
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day [ Time Frame: inclusion, 3 month, 6 month, 12 month ]
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months [ Time Frame: inclusion, 3 month, 6 month, 12 month ]
Complete list of historical versions of study NCT00798109 on ClinicalTrials.gov Archive Site
PANSS, GAF, number of DSM-IV criteria of cannabis dependence, May scale for treatment response, SF-12, la URICA, number of hospitalisation, mean number of joints per week, D9THC urinanalysis at 6M and cannabis consumption evaluated by the TLFB at 6M [ Time Frame: inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis ]
PANSS : global, positive, negative, general scores
PANSS, GAF, number of DSM-IV criteria of cannabis dependence, May scale for treatment response, SF-12, la URICA, number of hospitalisation, D9THC urinanalysis at 6M and cannabis consumption evaluated by the TLFB at 6M [ Time Frame: inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis ]
Not Provided
Not Provided
 
Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse
An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease
Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

Schizophrenia is a severe mental illness with a lifetime morbidity risk close to 1 %, involving both genetic and environmental risk factors. Prospective studies have shown that heavy use of cannabis in adolescence moderately increases the risk of developing schizophrenia. Many data have also suggested that the co-occurrence of cannabis abuse in patients with schizophrenia has a deleterious impact on the clinical outcome of schizophrenia. Cannabis abuse by schizophrenic patients is a significant public health problem for which there is no empirically validated treatment. We are presently studying the efficiency of motivational therapy on cannabis consumption in patients with schizophrenia.

330 patients with schizophrenia and cannabis abuse or dependence (according to DSM-IV criteria) are randomly assigned to 4 motivational interview during one month or usual intensive treatment. Treatment is conducted in outpatient which are evaluated at the inclusion and at 6 month with Time-Line Follow Bach for the consumption, PANSS score, number of relapse…). A outcome measure was urinalysis results providing an objective measure of cannabis use throughout the six month of the trial.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Schizophrenia
  • Cannabis Dependence, Continuous
  • Behavioral: Motivational therapy
    One hour of motivational therapy each weak during 4 weeks
  • Behavioral: Usual care
    Patients received at least six hour of usual therapy, as in the experimental group
  • Experimental: Motivational Therapy
    Four motivational interview for cannabis abuse in schizophrenia population during one month
    Intervention: Behavioral: Motivational therapy
  • Usual Care
    Usual care with intensive psychotherapy
    Intervention: Behavioral: Usual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
April 2013
October 2012   (Final data collection date for primary outcome measure)

INCLUSION CRITERIA:

  • Schizophrenia or schizo-affective disorder according to DSM-IV criteria
  • Meeting DSM-IV criteria for actual cannabis abuse or dependance
  • in current and regular contact with mental health service
  • with an age at interview of 18 years or more
  • No evidence of organic brain disease or clinically significant concurrent medical illness or learning disability
  • Written informed consent was obtained from all subjects (patients and parents).

EXCLUSION CRITERIA:

  • Not membership to a regime of social security or to a CMU
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00798109
P 070156
AOM 07007 ( Other Identifier: French Ministry )
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Caroline DUBERTRET, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP