Psychotic DisordersPhase 1NCT00783185
Dual Diagnosis (Psychosis and Cannabismisuse): Comparison of Specialized Treatment Versus Unspecified Treatment
A Phase 1 study testing Cannabis-Consumption-Reduction-Training and Social competence Training in people with Psychotic Disorders and Marijuana Abuse, run by University of Konstanz at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psychotic Disorders, Marijuana Abuse, Intervention
- What is being tested?
- Cannabis-Consumption-Reduction-Training and Social competence Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Jan 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Misuse of cannabis during 12 months preceding admission to hospital
Who cannot join
- Not able to attend training twice a week for 45 minutes (concentration, attention, psychotic symptoms, agitation)
- Discharge from hospital before completion of training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Diagnosis Psychosis and Substance Abuse: Short- and Middle-term Changes in Symptomatology After Visiting a Group Education Programme to Reduce Consumption of Cannabis
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.
Read the detailed 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.
- Conditions
- Psychotic Disorders, Marijuana Abuse, Intervention
- Being tested
- Cannabis-Consumption-Reduction-Training, Social competence Training
- Keywords
- psychotic disorders, cannabis, intervention
- Medical subject headings
- Psychotic Disorders, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabis-Consumption-Reduction-TrainingBehavioural
8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse
Social competence TrainingBehavioural
8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences
| Study group | Role | What they receive |
|---|---|---|
| ACT | Experimental | Anti-Cannabis-Consumption-Training Receives: Behavioral: Cannabis-Consumption-Reduction-Training |
| CG | Active comparator | Control group Receives: Behavioral: Social competence Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS Positive and Negative Symptom Scale
Measured: post intervention, six months follow-up
Secondary outcomes (1)
Urinstatus for cannabinoids
Measured: weekly during and post intervention, follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startJan 2006
- Primary completionJun 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Konstanz
- Sponsor type
- University, hospital or other
- Investigators
- Hans Watzl, Dr., Principal investigator, University of Konstanz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783185
- Sponsor's protocol ID
- CRET
- Status last verified
- Oct 2008
- First submitted
- 30 Oct 2008
- Last updated
- 12 Jan 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Diagnosis Psychosis and Substance Abuse: Short- and Middle-term Changes in Symptomatology After Visiting a Group Education Programme to Reduce Consumption of Cannabis
- ClinicalTrials.gov ID
- NCT00783185
- Acronym / sponsor ID
- CRET
- Conditions
- Psychotic Disorders, Marijuana Abuse, Intervention
- Keywords
- psychotic disorders, cannabis, intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of KonstanzUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 31 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT | Experimental | Behavioral: Cannabis-Consumption-Reduction-TrainingAnti-Cannabis-Consumption-Training |
| CG | Active comparator | Behavioral: Social competence TrainingControl group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of schizophrenia and disorders with psychotic features
- Misuse of cannabis during 12 months preceding admission to hospital
Key exclusion criteria (2 listed)
- Not able to attend training twice a week for 45 minutes (concentration, attention, psychotic symptoms, agitation)
- Discharge from hospital before completion of training
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis-Consumption-Reduction-Training8 sessions within 4 weeks (twice a week, 45 minutes each) Cognitive behavioral therapy with focus on cannabis abuse | Behavioural | ACT |
| Social competence Training8 sessions within 4 weeks (twice a week, 45 minutes) training to develop and ameliorate social competences | Behavioural | CG |
Primary outcome
PANSS Positive and Negative Symptom Scale
Time frame: post intervention, six months follow-up
1 secondary outcome
Urinstatus for cannabinoids
Time frame: weekly during and post intervention, follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
Related trials for Psychotic Disorders
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
RecruitingPhase 2/3
ACP-204 in Adults With Alzheimer's Disease Psychosis
Alzheimer's Disease Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Watzl, Dr. principal investigator
University of Konstanz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cannabis-Consumption-Reduction-Training and Social competence Training in people with Psychotic Disorders and Marijuana Abuse, run by University of Konstanz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PANSS Positive and Negative Symptom Scale (time frame: post intervention, six months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2010.