SCHIZOCAN: Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Completed

CT.gov ID

NCT00798109

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Cannabis Dependence, Continuous	Behavioral: Motivational therapy Behavioral: Usual care	N/A

Detailed Description

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

Study Type:

Interventional

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 :

Nov 1, 2008

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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
Other: Usual Care Usual care with intensive psychotherapy	Behavioral: Usual care Patients received at least six hour of usual therapy, as in the experimental group

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

Other: 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

Primary Outcome Measures

Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day [inclusion, 3 month, 6 month, 12 month]

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 [inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis]
PANSS : global, positive, negative, general scores

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).