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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00783185
Other study ID # CRET
Secondary ID
Status Completed
Phase Phase 1
First received October 30, 2008
Last updated January 11, 2010
Start date January 2006
Est. completion date January 2010

Study information

Verified date October 2008
Source University of Konstanz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

Intention of the study is to examine, if the symptomatology of dual diagnosis patients is less severe after a special indication training for reduction of cannabis consumption in comparison to unspecified trainings.

Point of interest is psychopathology and consumerism.


Description:

Dual diagnosis patients (psychosis and cannabis abuse) account for more clinical admissions than single diagnosis patients.

Cannabis misuse is a known risk factor for recurrence of psychosis.

A specified intervention on the basis of a manual for schizophrenic substance abusers is administered to inpatients in a specialized unit for young schizophrenic patients in a psychiatric hospital.

The control group, same indication (psychotic disorder and cannabis misuse) receives social competence training (specified for schizophrenic patients as well).

Admission to groups is randomly.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date January 2010
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Clinical diagnosis of schizophrenia and disorders with psychotic features

- Misuse of cannabis during 12 months preceding admission to hospital

Exclusion Criteria:

- Not able to attend training twice a week for 45 minutes (concentration, attention, psychotic symptoms, agitation)

- Discharge from hospital before completion of training

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Cannabis-Consumption-Reduction-Training
8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse
Social competence Training
8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences

Locations

Country Name City State
Germany University of Konstanz Konstanz Baden-Württemberg

Sponsors (1)

Lead Sponsor Collaborator
University of Konstanz

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary PANSS Positive and Negative Symptom Scale post intervention, six months follow-up No
Secondary Urinstatus for cannabinoids weekly during and post intervention, follow-up No
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