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Trial registered on ANZCTR


Registration number
ACTRN12607000286448
Ethics application status
Approved
Date submitted
5/10/2005
Date registered
29/05/2007
Date last updated
29/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A double blind randomised control trial on the effects of mirtazapine during the acute withdrawal in patients attending a cannabis dependency program with focus on anxiety, depression and sleep disturbances.
Scientific title
A double blind randomised control trial on the effects of mirtazapine during the acute withdrawal in patients attending a cannabis dependency program with focus on anxiety, depression and sleep disturbances.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cannabis Dependency 1827 0
Condition category
Condition code
Mental Health 1919 1919 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: oral mirtazapine 30mg taken daily at night for up to 4 weeks, 4-5 , 1 hour sessions in 4 weeks for structured cognitive-behavioural therapy for cannabis dependency plus sleep diary for the first two weeks.
Monitoring cannabis withdrawal especially sleep disturbance with a sleep diary for the first two weeks.
Intervention code [1] 697 0
Treatment: Drugs
Comparator / control treatment
Control intervention: 4-5 sessions in 4 weeks of structured cognitive-behavioural therapy for cannabis dependency plus sleep diary for the first two weeks.
Control group
Active

Outcomes
Primary outcome [1] 2732 0
Cannabis use (self report, urine testing).
Timepoint [1] 2732 0
Assessed at days 1, 28 and 56
Primary outcome [2] 2733 0
Other drug use (self report, urine testing).
Timepoint [2] 2733 0
Assessed at days 1, 28 and 57
Secondary outcome [1] 4608 0
Retention in counselling
Timepoint [1] 4608 0
Over 4 weeks

Eligibility
Key inclusion criteria
Cannabis dependence.
Minimum age
16 Years
Maximum age
69 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
On any antidepressant including mirtazapine; Unstable medical and psychiatric disorder; Pregnant or breastfeeding.

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)
Sealed envelopes containing group allocation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by selecting a sealed envelope from a box
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Researchers (outcome assessors and data analysts), clinicians and participants were blinded to group allocation
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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

Funding & Sponsors
Funding source category [1] 2065 0
Commercial sector/Industry
Name [1] 2065 0
Organon
Address [1] 2065 0
Country [1] 2065 0
Primary sponsor type
Hospital
Name
The Langton Centre
Address
Country
Australia
Secondary sponsor category [1] 1870 0
None
Name [1] 1870 0
nil
Address [1] 1870 0
Country [1] 1870 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3837 0
Langton Centre approved by South Eastern Sydney & Illawarra Area Health Service HREC
Ethics committee address [1] 3837 0
Ethics committee country [1] 3837 0
Australia
Date submitted for ethics approval [1] 3837 0
Approval date [1] 3837 0
21/09/2001
Ethics approval number [1] 3837 0
01/157

Summary
Brief summary
The wider trial aims to investigate whether the addition of mirtazapine improves the outcome and retention of patients undertaking a cognitive behavioural based intervention for cannabis dependency. In parallel, this project will give specific attention to the effects of mirtazapine on the severity of depression, anxiety and sleep disturbance during the acute withdrawal phase.

Hypothesis 1: Participants on active medication will experience milder withdrawal symptoms, (less anxiety, less depression and less symptoms of sleep disturbance) during the acute withdrawal phase from cannabis compared to those on placebo.

Hypothesis 2: Participants withdrawing from cannabis will show an improvement in sleep quality and quantity in the withdrawal stage from cannabis use, with symptoms significantly improving in the first 4 weeks post quit day.

Hypothesis 3: Mirtazapine leads to improved rate of abstinence following cannabis withdrawal by reducing anxiety, depression & sleep disturbance in the withdrawal phase.

Researchers, clinicians and participants were blinded to treatment allocation. A randomisation list was prepared prior to study commencement and kept off site At Sydney Hospital Pharmacy. Randomisation was carried out by the chief pharmacist at Sydney Hospital. As each participant was enrolled, the staff at the Langton Centre faxed Sydney Hospital with patient details and a request for randomisation. Study medication was dispensed by pharmacy staff. All active and placebo medication was identical in appearance and packaging.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35675 0
Address 35675 0
Country 35675 0
Phone 35675 0
Fax 35675 0
Email 35675 0
Contact person for public queries
Name 9886 0
Ms. Amie Frewen
Address 9886 0
The Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
Country 9886 0
Australia
Phone 9886 0
+61 2 93328777
Fax 9886 0
+61 2 93328700
Email 9886 0
frewena@sesahs.nsw.gov.au
Contact person for scientific queries
Name 814 0
Dr. Mark Montebello
Address 814 0
The Langton Centre
591 South Dowling Street
Surry Hills NSW 2010
Country 814 0
Australia
Phone 814 0
+61 2 93328777
Fax 814 0
+61 2 93328700
Email 814 0
montebellom@sesahs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary