Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000125921
Ethics application status
Approved
Date submitted
3/02/2011
Date registered
3/02/2011
Date last updated
8/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial of a Novel Cannabis Use Intervention Delivered by Telephone
Scientific title
Randomised Controlled Trial of a Novel Cannabis Use Intervention Delivered by Telephone
Secondary ID [1] 253540 0
University of New South Wales, Human Research Ethics Committee number: HREC08349
Universal Trial Number (UTN)
U1111-1119-2771
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Problematic cannabis use 261101 0
Condition category
Condition code
Public Health 259234 259234 0 0
Other public health
Mental Health 259241 259241 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 sessions of telephone counselling based on motivational interviewing techniques, cognitive behavioural therapy, models of behaviour change, and relapse prevention theory. Each session goes for approximately one hour and are delivered once a week. In addition participants will be mailed a self-help booklet that supplements the intervention.
Intervention code [1] 257970 0
Treatment: Other
Intervention code [2] 257974 0
Behaviour
Comparator / control treatment
Wait list control (no treatment)
Control group
Active

Outcomes
Primary outcome [1] 262066 0
Clinically meaningful reductions in cannabis use as assessed by a reduction of at least 50% in frequency of days of use and no report of any cannabis related problems as recorded on the Cannabis Problems Questionnaire
Timepoint [1] 262066 0
One month (directly after the intervention) and at three month follow up (two months post intervention)
Secondary outcome [1] 273079 0
Improvements in cannabis dependence as measured by the Severity of Cannabis Dependence Scale, quantity used on a typical day as measured utilising the TimeLine Follow Back method, and a measure of 90 day other substance use and two measures of overall functioning (Kessler 10 and the EuroQol-5D)
Timepoint [1] 273079 0
One month (directly after the intervention) and at three month follow up (two months post intervention)

Eligibility
Key inclusion criteria
Cannabis use in the 30 days prior to baseline interview
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Current or recent attendance in any drug or alcohol treatments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects are enrolled into the trial after an unprompted telephone call to the Cannabis Information and Helpline. Counsellors on the helpline are asked to inform any callers whom they feel would benefit from knowing about the trial. Interested parties leave their telephone number and are called back for inclusion criteria screening. Once successful the participants are randomly allocated into intervention or control group by a software program capable of producing randomised results
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A software program produced a randomised list
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
160 individuals completed baseline, and 110 completed both follow up assessments
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/04/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258425 0
Government body
Name [1] 258425 0
Australian Government Department of Health and Aging
Country [1] 258425 0
Australia
Primary sponsor type
Government body
Name
National Cannabis Prevention and Information Centre
Address
National Cannabis Prevention and Information Centre (NCPIC)
PO Box 684
Randwick NSW 2031
Australia
Country
Australia
Secondary sponsor category [1] 257573 0
None
Name [1] 257573 0
Address [1] 257573 0
Country [1] 257573 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260406 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 260406 0
Ethics committee country [1] 260406 0
Date submitted for ethics approval [1] 260406 0
Approval date [1] 260406 0
10/03/2009
Ethics approval number [1] 260406 0
08349

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32166 0
Address 32166 0
Country 32166 0
Phone 32166 0
Fax 32166 0
Email 32166 0
Contact person for public queries
Name 15413 0
Peter Gates
Address 15413 0
National Cannabis Prevention and Information Centre (NCPIC)
PO Box 684
Randwick NSW 2031
Australia
Country 15413 0
Australia
Phone 15413 0
+61 2 93850269
Fax 15413 0
Email 15413 0
[email protected]
Contact person for scientific queries
Name 6341 0
Peter Gates
Address 6341 0
National Cannabis Prevention and Information Centre (NCPIC)
PO Box 684
Randwick NSW 2031
Australia
Country 6341 0
Australia
Phone 6341 0
0293850269
Fax 6341 0
Email 6341 0
[email protected]

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.