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

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ClinicalTrials.gov Identifier: NCT00798109
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : June 16, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Schizophrenia Cannabis Dependence, Continuous Behavioral: Motivational therapy Behavioral: Usual care Not Applicable

Detailed Description:

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease
Study Start Date : November 2008
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2013

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Motivational Therapy
Four motivational interview for cannabis abuse in schizophrenia population during one month
 Behavioral: Motivational therapy
One hour of motivational therapy each weak during 4 weeks
Usual Care
Usual care with intensive psychotherapy
 Behavioral: Usual care
Patients received at least six hour of usual therapy, as in the experimental group


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00798109


Locations
France
Service de psychiatrie (Pr Adès)
Colombes, France, 92700
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Caroline DUBERTRET, MD,PhD Assistance Publique - Hôpitaux de Paris
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00798109     History of Changes
Other Study ID Numbers: P 070156
AOM 07007 ( Other Identifier: French Ministry )
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: June 16, 2014
Last Verified: June 2014

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Schizophrenia
Cannabis misuse comorbidity
Motivational interview
Randomised open trial

Additional relevant MeSH terms:
Schizophrenia
Marijuana Abuse
Substance-Related Disorders
 Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Chemically-Induced Disorders