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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
Scientific title
Cannabidiol (CBD) for the Management of Cannabis Withdrawal: A Phase II Proof of Concept Study
Secondary ID [1] 284167 0
Nil
Universal Trial Number (UTN)
U1111-1153-9442
Trial acronym
CBD study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Withdrawal 291264 0
Condition category
Condition code
Other 291609 291609 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Mental Health 291645 291645 0 0
Addiction

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 288867 0
Treatment: Drugs
Comparator / control treatment
N/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291550 0
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.
Timepoint [1] 291550 0
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.
Secondary outcome [1] 307053 0
Retention in treatment
Abstinence at 28 day followup
Timepoint [1] 307053 0
Day 7 post admission and again at day 28 post admission.

Eligibility
Key inclusion criteria
Cannabis dependency
Adult
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Small n=5 phase II proof of concept study
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2148 0
Nepean Hospital - Kingswood
Recruitment postcode(s) [1] 7827 0
2747 - Kingswood

Funding & Sponsors
Funding source category [1] 288797 0
University
Name [1] 288797 0
University of NSW(UNSW) -National Cannabis Prevention and Information Centre (NCPIC) core funds
Address [1] 288797 0
22-32 King Street, Randwick, NSW, 2031
Country [1] 288797 0
Australia
Primary sponsor type
University
Name
UNSW
Address
22-32 King Street
Randwick NSW 2031
Country
Australia
Secondary sponsor category [1] 287492 0
None
Name [1] 287492 0
n/a
Address [1] 287492 0
n/a
Country [1] 287492 0
Other collaborator category [1] 277842 0
Hospital
Name [1] 277842 0
Cumberland Hospital
Address [1] 277842 0
Building 83, 1-11 Hainsowrth Street, Westmead, NSW 2145
Country [1] 277842 0
Australia
Other collaborator category [2] 277852 0
Hospital
Name [2] 277852 0
Nepean Hospital
Address [2] 277852 0
Somerset Street, Kingswood, NSW, 2747
Country [2] 277852 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290640 0
Western Sydney Local Health District
Ethics committee address [1] 290640 0
Western Sydney Local Health District Office, Westmead Hospital Campus, Institute Road, Westmead NSW 2145
Ethics committee country [1] 290640 0
Australia
Date submitted for ethics approval [1] 290640 0
Approval date [1] 290640 0
28/10/2013
Ethics approval number [1] 290640 0
HREC2013/9/4.6 (3774) AU RED HREC/13/WMEAD/229

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46562 0
Prof Jan Copeland
Address 46562 0
NCPIC-UNSW
22-32 King Street
Randwick, NSW, 2031
Country 46562 0
Australia
Phone 46562 0
+61 2 93850231
Fax 46562 0
+61 293850201
Email 46562 0
j.copeland@unsw.edu.au
Contact person for public queries
Name 46563 0
Dr Nicole Clement
Address 46563 0
NCPIC-UNSW
22-32 King Street
Randwick, NSW, 2031
Country 46563 0
Australia
Phone 46563 0
+61 417651223
Fax 46563 0
+61 293850201
Email 46563 0
n.clement@unsw.edu.au
Contact person for scientific queries
Name 46564 0
Prof Jan Copeland
Address 46564 0
NCPIC-UNSW
22-32 King Street
Randwick, NSW, 2031
Country 46564 0
Australia
Phone 46564 0
+61 293850231
Fax 46564 0
+61 293850201
Email 46564 0
j.copeland@unsw.edu.au

No information has been provided regarding IPD availability
Summary results
No Results