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Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse (SCHIZOCAN)
This study is currently recruiting participants.
Verified by Assistance Publique - Hôpitaux de Paris, November 2008
Sponsored by: Assistance Publique - Hôpitaux de Paris
Information provided by: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00798109
  Purpose

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 Intervention
Schizophrenia
Cannabis Abuse/Dependence
Behavioral: Motivational therapy
Behavioral: Usual care

MedlinePlus related topics: Mental Health Schizophrenia
Drug Information available for: Cannabis GW-1000
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Cannabis consumption evaluated by the Time-Line Follow Back at 6 months [ Time Frame: inclusion, 3 month, 6 month, 12 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 330
Study Start Date: November 2008
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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
B
Usual care with intensive psychotherapy
Behavioral: Usual care
Patients received at least six hour of usual therapy, as in the experimental group

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00798109

Contacts
Contact: Caroline DUBERTRET, MD,PhD 0147606413 caroline.dubertret@lmr.aphp.fr
Contact: Lucia Romo, PhD 0687511271 lucia.romo@wanadoo.fr

Locations
France
Service de psychiatrie (Pr Adès) Recruiting
Colombes, France, 92700
Contact: Caroline Dubertret, MD,PhD     +33 (0) 1 47 60 64 13     caroline.dubertret@lmr.aphp.fr    
Contact: Caroline Dubertret, MD,PhD     +33 (0) 1 47 60 64 13     caroline.dubertret@lmr.aphp.fr    
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Caroline DUBERTRET, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Department Clinical Research of Developpement ( Amel Ouslimani )
Study ID Numbers: P 070156, AOM 07007
Study First Received: September 30, 2008
Last Updated: November 24, 2008
ClinicalTrials.gov Identifier: NCT00798109  
Health Authority: France: Ministry of Health

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

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Substance-Related Disorders
Disorders of Environmental Origin
Psychotic Disorders
Marijuana Abuse
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 16, 2009