Crystalline methamphetamine (aka “ice”) is a significant and growing public health concern in Australia, with ~300,000 Australians now dependent on this drug. There are currently no approved pharmacotherapies that can be delivered as scalable and cost-effective treatment options to manage growing treatment demand. Mirtazapine has recently been identified as the first medication to be effective in two consecutive Phase II clinical trials for methamphetamine dependence. Mirtazapine is currently an approved generic antidepressant medication that can be delivered as a prescribed take-home medication, making it a potentially scalable and cost-effective treatment option. There is now a need for a Phase III trial to confirm that mirtazapine is a feasible, safe and effective treatment for methamphetamine dependence in routine clinical practice. We will conduct a Phase III double-blind placebo-controlled randomised trial (N = 340) to assess the effectiveness, safety and tolerability of mirtazapine in the management of methamphetamine dependence within routine clinical care settings. This 12-week trial will be powered to allow us to confirm whether mirtazapine has a clinically relevant benefit on methamphetamine use. We will use a pragmatic and inclusive trial design with feasible implementation procedures that will establish realistic treatment effects and facilitate translation into practice.
|Effective start/end date||1/06/21 → 31/05/25|
- mental health
- clinical trial
- population health