NCT00783185

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2006

Longer than P75 for phase_1

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

Study Start

First participant enrolled

January 1, 2006

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

January 12, 2010

Status Verified

October 1, 2008

Enrollment Period

3.4 years

First QC Date

October 30, 2008

Last Update Submit

January 11, 2010

Conditions

Psychotic DisordersMarijuana AbuseIntervention

Keywords

psychotic disorderscannabisintervention

Outcome Measures

Primary Outcomes (1)

  • PANSS Positive and Negative Symptom Scale

    post intervention, six months follow-up

Secondary Outcomes (1)

  • Urinstatus for cannabinoids

    weekly during and post intervention, follow-up

Study Arms (2)

ACT

EXPERIMENTAL

Anti-Cannabis-Consumption-Training

Behavioral: Cannabis-Consumption-Reduction-Training

CG

ACTIVE COMPARATOR

Control group

Behavioral: Social competence Training

Interventions

Cannabis-Consumption-Reduction-TrainingBEHAVIORAL

8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse

ACT
Social competence TrainingBEHAVIORAL

8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences

CG

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of schizophrenia and disorders with psychotic features
  • Misuse of cannabis during 12 months preceding admission to hospital

You may not qualify if:

  • Not able to attend training twice a week for 45 minutes (concentration, attention, psychotic symptoms, agitation)
  • Discharge from hospital before completion of training

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Konstanz

Konstanz, Baden-Wurttemberg, 78462, Germany

Location

MeSH Terms

Conditions

Psychotic DisordersMarijuana Abuse

Condition Hierarchy (Ancestors)

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

Study Officials

  • Hans Watzl, Dr.

    University of Konstanz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 30, 2008

First Posted

October 31, 2008

Study Start

January 1, 2006

Primary Completion

June 1, 2009

Study Completion

January 1, 2010

Last Updated

January 12, 2010

Record last verified: 2008-10

Locations

DE(1)