SchizophreniaSCHIZOCANNCT00798109
Effect of Motivational Therapy on Schizophrenia With Cannabis Misuse
A study testing Motivational therapy in people with Schizophrenia and Cannabis Dependence, Continuous, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Cannabis Dependence, Continuous
- What is being tested?
- Motivational therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Apr 2013
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Not membership to a regime of social security or to a CMU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease
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.
Read the detailed 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.
- Conditions
- Schizophrenia, Cannabis Dependence, Continuous
- Being tested
- Motivational therapy, Usual care
- Keywords
- Schizophrenia, Cannabis misuse comorbidity, Motivational interview, Randomised open trial
- Medical subject headings
- Schizophrenia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational therapyBehavioural
One hour of motivational therapy each weak during 4 weeks
Usual careBehavioural
Patients received at least six hour of usual therapy, as in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| Motivational Therapy | Experimental | Four motivational interview for cannabis abuse in schizophrenia population during one month Receives: Behavioral: Motivational therapy |
| Usual Care | Other | Usual care with intensive psychotherapy Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day
Measured: 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
PANSS : global, positive, negative, general scores
Measured: inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline DUBERTRET, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00798109
- Sponsor's protocol ID
- P 070156
- Other IDs
- AOM 07007
- Acronym
- SCHIZOCAN
- Status last verified
- Jun 2014
- First submitted
- 30 Sep 2008
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multicentric Randomized Clinical Trial Assessing the Impact of Motivational Interviewing on Cannabis Consumption in Patients With Psychiatric Disease
- ClinicalTrials.gov ID
- NCT00798109
- Acronym / sponsor ID
- SCHIZOCAN / P 070156
- Conditions
- Schizophrenia, Cannabis Dependence, Continuous
- Keywords
- Schizophrenia, Cannabis misuse comorbidity, Motivational interview, Randomised open trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 25 Nov 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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Therapy | Experimental | Behavioral: Motivational therapyFour motivational interview for cannabis abuse in schizophrenia population during one month |
| Usual Care | Other | Behavioral: Usual careUsual care with intensive psychotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Not membership to a regime of social security or to a CMU
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 |
|---|---|---|
| Motivational therapyOne hour of motivational therapy each weak during 4 weeks | Behavioural | Motivational Therapy |
| Usual carePatients received at least six hour of usual therapy, as in the experimental group | Behavioural | Usual Care |
Primary outcome
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day
Time frame: inclusion, 3 month, 6 month, 12 month
1 secondary outcome
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
Time frame: inclusion, 3 month, 6 month, 12 month. Only inclusion and 6 month for urianalysis
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 16 Jun 2014.
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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.
Caroline DUBERTRET, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational therapy in people with Schizophrenia and Cannabis Dependence, Continuous, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 6 inclusion and 1 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 16 Jun 2014. 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 France. 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.
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?
Cannabis consumption evaluated by the Time-Line Follow Back at 6 months with mean percentage of abstinent day (time frame: inclusion, 3 month, 6 month, 12 month). 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 16 Jun 2014.