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Trial registered on ANZCTR
Registration number
ACTRN12614000248662
Ethics application status
Approved
Date submitted
27/02/2014
Date registered
7/03/2014
Date last updated
7/03/2014
Type of registration
Prospectively registered
Titles & IDs
Public title
Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
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Scientific title
Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
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Secondary ID [1]
284167
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Nil
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Universal Trial Number (UTN)
U1111-1153-9442
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Trial acronym
CBD study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cannabis Withdrawal
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Condition category
Condition code
Other
291609
291609
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Mental Health
291645
291645
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Single subject repeated measures design of an open label administration of Cannabidiol to 5 subjects withdrawing from cannabis use in an inpatient setting. 300mg of CBD will be administered once on day 1, twice bd on days 2-5 and once on day 6. participants will be discharged on day 7. CBD will be administered orally in capsules.
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Intervention code [1]
288867
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Treatment: Drugs
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Comparator / control treatment
N/a
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Reduction of number and severity of withdrawal symptoms including-Insomnia, anxiety, agitation, restlessness, low mood.The Cannabis Withdrawal Cale will be used to monitor symptoms.
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Assessment method [1]
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Timepoint [1]
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Day 7 discharge. Patients will be monitored for number of symptoms and withdrawal severity each day using the Cannabis Withdrawal scale. Patients will undergo Urine and blood testing on day 1, day 4 and day 7, then again on day 28.
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Secondary outcome [1]
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Retention in treatment
Abstinence at 28 day followup
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Assessment method [1]
307053
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Timepoint [1]
307053
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Day 7 post admission and again at day 28 post admission.
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Eligibility
Key inclusion criteria
Cannabis dependency
Adult
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Poly substance dependence, Co-morbid Mental Health Diagnosis, Intellectual disability, Substance abuse treatment in previous 30 days, Evidence of severe medical condition (cardiac, renal, hepatic), Pregnant women or those wishing to start a family imminently, not willing to abide by NSW Health rules for inpatient admission.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Open label study with participants recruited on a first in first served basis once inclusion and exclusion criteria have been met.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Small n=5 phase II proof of concept study
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Phase
Phase 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
There is not statistical assumptions needed for this type of study as it is a single subject n=1 design where the procedure is repeated 4 more times to verify any changes in the initial subject. This is a well known and validated experimental design.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
21/03/2014
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
5
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
2148
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Nepean Hospital - Kingswood
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Recruitment postcode(s) [1]
7827
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2747 - Kingswood
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of NSW(UNSW) -National Cannabis Prevention and Information Centre (NCPIC) core funds
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Address [1]
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22-32 King Street, Randwick, NSW, 2031
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Country [1]
288797
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Australia
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Primary sponsor type
University
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Name
UNSW
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Address
22-32 King Street
Randwick NSW 2031
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
287492
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n/a
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Address [1]
287492
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n/a
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Country [1]
287492
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Other collaborator category [1]
277842
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Hospital
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Name [1]
277842
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Cumberland Hospital
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Address [1]
277842
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Building 83, 1-11 Hainsowrth Street, Westmead, NSW 2145
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Country [1]
277842
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Australia
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Other collaborator category [2]
277852
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Hospital
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Name [2]
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Nepean Hospital
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Address [2]
277852
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Somerset Street, Kingswood, NSW, 2747
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Country [2]
277852
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Western Sydney Local Health District
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Ethics committee address [1]
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Western Sydney Local Health District Office, Westmead Hospital Campus, Institute Road, Westmead NSW 2145
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
290640
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Approval date [1]
290640
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28/10/2013
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Ethics approval number [1]
290640
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HREC2013/9/4.6 (3774) AU RED HREC/13/WMEAD/229
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Summary
Brief summary
The aim of the study is to examine the safety and efficacy of cannabidiol (CBD) in the inpatient management of cannabis withdrawal in an open label study. Specifically the study will assess the impact of CBD on the number and severity of withdrawal symptoms, detoxification completion and adverse events in n=5, using an intention to treat analysis.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Jan Copeland
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Address
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NCPIC-UNSW
22-32 King Street
Randwick, NSW, 2031
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Country
46562
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Australia
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Phone
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+61 2 93850231
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Fax
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+61 293850201
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Nicole Clement
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Address
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NCPIC-UNSW
22-32 King Street
Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61 417651223
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Fax
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+61 293850201
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Email
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[email protected]
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Contact person for scientific queries
Name
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Prof Jan Copeland
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Address
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NCPIC-UNSW
22-32 King Street
Randwick, NSW, 2031
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Country
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Australia
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Phone
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+61 293850231
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Fax
46564
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+61 293850201
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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