Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse (SCHIZOCAN)
Primary Purpose
Schizophrenia, Cannabis Dependence, Continuous
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Motivational therapy
Usual care
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Cannabis misuse comorbidity, Motivational interview, Randomised open trial
Eligibility 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
Sites / Locations
- Service de psychiatrie (Pr Adès)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Motivational Therapy
Usual Care
Arm Description
Four motivational interview for cannabis abuse in schizophrenia population during one month
Usual care with intensive psychotherapy
Outcomes
Primary Outcome Measures
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day
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, mean number of joints per week, D9THC urinanalysis at 6M and cannabis consumption evaluated by the TLFB at 6M
PANSS : global, positive, negative, general scores
Full Information
NCT ID
NCT00798109
First Posted
September 30, 2008
Last Updated
June 13, 2014
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT00798109
Brief Title
Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse
Acronym
SCHIZOCAN
Official Title
An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Cannabis Dependence, Continuous
Keywords
Schizophrenia, Cannabis misuse comorbidity, Motivational interview, Randomised open trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Therapy
Arm Type
Experimental
Arm Description
Four motivational interview for cannabis abuse in schizophrenia population during one month
Arm Title
Usual Care
Arm Type
Other
Arm Description
Usual care with intensive psychotherapy
Intervention Type
Behavioral
Intervention Name(s)
Motivational therapy
Intervention Description
One hour of motivational therapy each weak during 4 weeks
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Patients received at least six hour of usual therapy, as in the experimental group
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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
Description
PANSS : global, positive, negative, general scores
Time Frame
inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline DUBERTRET, MD,PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service de psychiatrie (Pr Adès)
City
Colombes
ZIP/Postal Code
92700
Country
France
12. IPD Sharing Statement
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Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse
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