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ISRCTN
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ISRCTN33576045
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ClinicalTrials.gov identifier
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Public title
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Contingency Intervention for Reduction of Cannabis in earLy psychosis
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Scientific title
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Randomised controlled trial of the clinical and cost-effectiveness of a contingency management intervention for reduction of cannabis use and of relapse in early psychosis
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Acronym
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CIRCLe
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Serial number at source
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09/144/50
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Study hypothesis
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Time to relapse will be significantly greater in a group of early intervention service users who receive psychoeducation combined with contingency management (voucher rewards for evidence of abstinence) than in a group who receive the psychoeducation only.
More details can be found at http://www.hta.ac.uk/2578
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Lay summary
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Lay summary under review
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Ethics approval
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Not provided at time of registration
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Study design
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Feasibility pilot individually randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Psychotic illnesses including schizophrenia, schizo-affective disorder and bipolar disorder with psychotic symptoms
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Participants - inclusion criteria
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1. Under the care of an early intervention service for psychosis
2. Diagnostic criteria for EIS entry require a first psychotic episode significantly impairing functioning and lasting more than a week
3. Problematic cannabis use is operationalised as having used cannabis at least once in at least 12 of the previous 24 weeks
4. Aged 18-39, male and female participants
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Participants - exclusion criteria
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Insufficient English to complete the study assessments
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Anticipated start date
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01/01/2011
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Anticipated end date
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30/06/2016
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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544 including 68 participants in feasibility pilot study
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Interventions
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Experimental group: Contingency management involving voucher rewards for abstinence demonstrated by urinalysis together with psychoeducation delivered by care coordinators.
Control group: Psychoeducation only
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Primary outcome measure(s)
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1. Time to relapse, measured over 18 months
2. Admission to hospital or a crisis team will be used to indicate relapse
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Secondary outcome measure(s)
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1. Presence of cannabis on urinalysis at 3 months and at 18 months of follow up
2. Positive symptom severity measured by Positive and Negative Syndrome Scale (PANSS)
3. Engagement in work or study at 18 months
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Sources of funding
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NIHR Health Techology Assessment Programme - HTA (UK) ref: 09/144/50
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Trial website
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Publications
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Contact name
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Prof
Sonia
Johnson
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Address
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Mental Health Sciences Unit
University College London
Charles Bell House
67-73 Riding House Street
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City/town
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London
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Zip/Postcode
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W1W 7EY
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Country
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United Kingdom
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Email
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s.johnson@ucl.ac.uk
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Sponsor
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University College London (UK)
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Address
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c/o Dr Nick McNally
Director of Research Support
Joint University College London Hospitals/ University College London/ Royal Free Hospital Biomedical Research Unit
25 Grafton Way
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City/town
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London
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Zip/Postcode
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WC1E 6DB
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Country
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United Kingdom
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Sponsor website:
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http://www.ucl.ac.uk/joint-rd-unit/
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Date applied
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20/10/2011
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Last edited
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28/11/2011
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Date ISRCTN assigned
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28/11/2011
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