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Trial registered on ANZCTR


Registration number
ACTRN12609000581268
Ethics application status
Approved
Date submitted
25/09/2008
Date registered
14/07/2009
Date last updated
14/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of a novel combination pharmacotherapy program for the treatment of cannabis dependence
Scientific title
A randomised double blind placebo controlled trial of combination pharmacotherapy using mirtazapine, acamprosate and tiagabine for the treatment of cannabis dependence
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cannabis dependence 3747 0
Condition category
Condition code
Mental Health 3925 3925 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Active 12 week pharmacological treatment arm using a combination of mirtazapine (30mg oral daily), acamprosate (999mg oral twice daily) and tiagabine (5mg oral twice daily) versus a placebo medication treatment arm. All subjects (active medication and placebo) also receive weekly, nurse-based, supportive counseling and assistance with pharmacological compliance and a 6 session manualised cognitive behavioral cannabis treatment program (1 session per week for 6 weeks)
Intervention code [1] 3462 0
Treatment: Drugs
Comparator / control treatment
oral starch-based placebo capsules for 12 weeks; weekly, nurse-based, supportive counseling and assistance with pharmacological compliance and a 6 session manualised cognitive behavioral cannabis treatment program (1 session per week for 6 weeks)
Control group
Placebo

Outcomes
Primary outcome [1] 4821 0
proportion (%) of patients achieving and maintaining abstinence from cannabis, as measured by self report and confirmed by quantitative urinalysis
Timepoint [1] 4821 0
at 4 weeks, and 3 and 6 months after commencing treatment
Secondary outcome [1] 8143 0
percentage cannabis free days as measured by Timeline Follow Back (TLFB) interview
Timepoint [1] 8143 0
at 4 weeks, and 3 and 6 months after commencing treatment
Secondary outcome [2] 8144 0
reduction in cannabis use (volume and $ expenditure) as measured by Timeline Follow Back (TLFB) interview
Timepoint [2] 8144 0
at 4 weeks, and 3 and 6 months after commencing treatment
Secondary outcome [3] 8145 0
mental health and psychosocial functioning as measured by SF-12 General Health Questionnaire, GAD 7, and K10 (Kessler Psychological Distress Scale)
Timepoint [3] 8145 0
at 4 weeks, and 3 and 6 months after commencing treatment

Eligibility
Key inclusion criteria
using cannabis daily for at least 3 months
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
less than 18 years of age; inability to take oral medicaton; concurrent medical illness requiring acute care hospitalisation or treatment; severe renal or liver disease; pregnancy

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)
allocation by contacting the holder of the allocation schedule at a central administration point
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomization table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

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)

Funding & Sponsors
Funding source category [1] 3926 0
Hospital
Name [1] 3926 0
St Vincents, Melbourne
Address [1] 3926 0
PO Box 2900 Fitzroy Victoria Australia 3065
Country [1] 3926 0
Australia
Primary sponsor type
Hospital
Name
St Vincents, Melbourne
Address
PO Box 2900 Fitzroy Victoria Australia 3065
Country
Australia
Secondary sponsor category [1] 3520 0
None
Name [1] 3520 0
Address [1] 3520 0
Country [1] 3520 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5992 0
St Vincent's, Melbourne
Ethics committee address [1] 5992 0
PO Box 2900 Fitzroy Victoria Australia 3065
Ethics committee country [1] 5992 0
Australia
Date submitted for ethics approval [1] 5992 0
31/07/2008
Approval date [1] 5992 0
18/03/2009
Ethics approval number [1] 5992 0
HREC-D 083/08

Summary
Brief summary
Cannabis is often a difficult drug to stop, and its regular use often causes dependence and withdrawal symptoms when attempting to stop. In Australia, the major treatment available for cannabis dependence is counselling, but many individuals find that counselling for cannabis use is not effective, particularly because of the withdrawal symptoms that occur.
This project will assess a new treatment for cannabis dependence in patients who are seeking treatment to stop their cannabis use, and uses a combination of medications that aim to block the effects of cannabis withdrawal in the brain, and so reduce the severity of cannabis withdrawal symptoms. The three medications used in combination are tiagabine, acamprosate and mirtazapine.
Participants will be allocated to one of two treatment groups. One treatment group will receive a combination of the three active medications, tiagabine, acamprosate and mirtazapine for a period of 12 weeks. The second treatment group will receive placebo (dummy) medications for 12 weeks. Allocation to either group will be by a randomisation process – like flipping a coin.
All patients in the trial will also receive a program of weekly counselling and support. Patients will participate in the trial for a period of six months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28975 0
Address 28975 0
Country 28975 0
Phone 28975 0
Fax 28975 0
Email 28975 0
Contact person for public queries
Name 12132 0
Prof Jon Currie
Address 12132 0
PO Box 2900 Fitzroy Victoria Australia 3065
Country 12132 0
Australia
Phone 12132 0
61 3 92883467
Fax 12132 0
Email 12132 0
jade.cruse@svhm.org.au
Contact person for scientific queries
Name 3060 0
Prof Jon Currie
Address 3060 0
PO Box 2900 Fitzroy Victoria Australia 3065
Country 3060 0
Australia
Phone 3060 0
61 3 92883467
Fax 3060 0
Email 3060 0
jon.currie@svhm.org.au

No data has been provided for results reporting
Summary results
Not applicable