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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00798109
First received: September 30, 2008
Last updated: June 13, 2014
Last verified: June 2014

September 30, 2008
June 13, 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 ] [ Designated as safety issue: No ]
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 ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Schizophrenia
  • Cannabis Dependence, Continuous
  • Behavioral: Motivational therapy
    One hour of motivational therapy each weak during 4 weeks
    Other Name: Motivational therapy
  • Behavioral: Usual care
    Patients received at least six hour of usual therapy, as in the experimental group
    Other Name: Usual care
  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00798109
P 070156, AOM 07007
No
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