NCT00798109

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline
Completed

Started Nov 2008

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

3.9 years

First QC Date

September 30, 2008

Last Update Submit

June 13, 2014

Conditions

Keywords

SchizophreniaCannabis misuse comorbidityMotivational interviewRandomised open trial

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Motivational Therapy

EXPERIMENTAL

Four motivational interview for cannabis abuse in schizophrenia population during one month

Behavioral: Motivational therapy

Usual Care

OTHER

Usual care with intensive psychotherapy

Behavioral: Usual care

Interventions

One hour of motivational therapy each weak during 4 weeks

Motivational Therapy
Usual careBEHAVIORAL

Patients received at least six hour of usual therapy, as in the experimental group

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • Not membership to a regime of social security or to a CMU

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de psychiatrie (Pr Adès)

Colombes, 92700, France

Location

MeSH Terms

Conditions

SchizophreniaMarijuana Abuse

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Officials

  • Caroline DUBERTRET, MD,PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2008

First Posted

November 25, 2008

Study Start

November 1, 2008

Primary Completion

October 1, 2012

Study Completion

April 1, 2013

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations