Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse

Schizophrenia Clinical Trial

— SCHIZOCAN  

Official title:

An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00798109
• Other study ID #: P 070156
• Secondary ID: AOM 07007
• Status: Completed
• Phase: N/A
• First received: September 30, 2008
• Last updated: June 13, 2014
• Start date: November 2008
• Est. completion date: April 2013

Study information

• Verified date: June 2014
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis Dependence, Continuous
• Marijuana Abuse
• Schizophrenia
• Substance-Related Disorders

Intervention

Behavioral:
• Motivational therapy
One hour of motivational therapy each weak during 4 weeks
• Usual care
Patients received at least six hour of usual therapy, as in the experimental group

Locations

Country	Name	City	State
France	Service de psychiatrie (Pr Adès)	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis	No