Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse (SCHIZOCAN)
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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 Dependence, Continuous |
Behavioral: Motivational therapy Behavioral: Usual care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]PANSS : global, positive, negative, general scores
| Enrollment: | 97 |
| Study Start Date: | November 2008 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: Motivational therapy
|
|
Usual Care
Usual care with intensive psychotherapy
|
Behavioral: Usual care
Patients received at least six hour of usual therapy, as in the experimental group
Other Name: Usual care
|
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 |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00798109
| France | |
| Service de psychiatrie (Pr Adès) | |
| Colombes, France, 92700 | |
| Principal Investigator: | Caroline DUBERTRET, MD,PhD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00798109 History of Changes |
| Other Study ID Numbers: | P 070156, AOM 07007 |
| Study First Received: | September 30, 2008 |
| Last Updated: | June 13, 2014 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Schizophrenia Cannabis misuse comorbidity Motivational interview Randomised open trial |
Additional relevant MeSH terms:
|
Marijuana Abuse Schizophrenia Substance-Related Disorders |
Chemically-Induced Disorders Mental Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on February 26, 2015