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.

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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.

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