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Introduction: Contingency management (CM) is the most effective treatment for reducing methamphetamine use. We sought to understand why CM has not been taken up to manage methamphetamine use disorder in Australia., Methods: Six focus groups (4-8 participants per group) were conducted with health workers from agencies in Australia that provided drug-related health care to people who use methamphetamine. These agencies had no previous experience delivering CM for substance use. The potential acceptability and feasibility of implementing CM in their services were discussed., Results: Participants felt that it would be beneficial to have an evidence-based treatment for methamphetamine use disorder. This sentiment was offset by concerns that CM conflicted with a client-centred harm-reduction approach and that it dictated the goal of treatment as abstinence. It was also perceived as potentially coercive and seen to reify the power imbalance in the therapeutic relationship and therefore potentially reinforce stigma. There was also concern about the public's perception and the political acceptability of CM, who would fund CM, and the inequity of providing incentives only to clients with a methamphetamine use disorder. Some concerns could be ameliorated if the goals and structure of CM could be tailored to a client's needs., Discussion and Conclusions: Many healthcare workers were keen to offer CM as an effective treatment option for people with methamphetamine use disorder, but CM would need to be sufficiently flexible to allow it to be tailored to client needs and implemented in a way that did not adversely impact the therapeutic relationship., (© 2024 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)

Background: There are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder., Methods: This is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles., Discussion: This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine., Trial Registration: Australian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022., (© 2024. The Author(s).)

Introduction: There is little knowledge of the perspectives of people who use methamphetamine and have participated in clinical trials, and none for interventions not intended to address abstinence. A better understanding of these experiences could lead to more patient centred clinical trial design. This study seeks to understand the experiences of people who completed a clinical trial of lisdexamfetamine for the treatment of acute methamphetamine withdrawal., Methods: Thematic analysis of open-ended, semi-structured interviews with eight people who participated in an inpatient clinical trial of lisdexamfetamine for acute methamphetamine withdrawal. Interviews were conducted between days 3 and 6 of admission to an inner-city Sydney hospital., Results: Participants described how research procedures, the research setting, and the investigational product affected their experiences while enrolled in a clinical trial. Of particular importance to participants were transparent and low burden trial procedures, a welcoming trial environment, trusting relationships and effective communication, which were linked with the participants' subsequent decision to remain enrolled in the trial., Discussion: The experiences of participants in this clinical trial can be distilled into four meta-themes: agency, caring-trust, safety, and communication. Participants spontaneously linked these experiences with a capacity to remain enrolled in the study. By considering the experiences of trial participants in clinical trial design, researchers can improve the experiences of future trial participants and facilitate their choice to remain enrolled in clinical trials., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: LSA is supported by an NDARC PhD Scholarship. MF has received unrestricted funding for research purposes from Indivior and Sequiiris. SS has received clinical research supplies from Alkermes. NE and KJS are employed by NCCRED. No other investigators have any conflicts of interest to declare., (Copyright © 2024. Published by Elsevier B.V.)

Introduction: Contingency management (CM) is currently the most efficacious treatment for methamphetamine use, yet it is rarely available in routine care. We examined the viewpoints of people who use methamphetamine on CM as a potential treatment for methamphetamine use disorder., Methods: Semi-structured qualitative interviews with 30 Australians aged 18 years or older who had used methamphetamine at least weekly in the past 6 months., Results: Participants reported overall positive attitudes towards CM as a potential treatment option for methamphetamine use disorder. However, there was need for greater flexibility in meeting participant treatment goals (e.g., reduced use or complete abstinence), with particular concern about the viability of initiating abstinence, both in terms of the sufficiency of the initial financial incentive and managing withdrawal symptoms. There was strong interest in the use of digital technologies to provide remote CM, particularly around the convenience and flexibility this offered. Despite this, participants remained keen to access adjunctive treatment and support services but stressed that engagement with these additional services should not be mandatory. Marketing of CM will need to address preconceptions about drug-testing used in abstinence-based CM being punitive (especially urine testing) and its connotations with criminal justice interventions., Discussion and Conclusion: Positive attitudes towards CM bode well for potential uptake should CM be made available in routine clinical practice. However, there is a need to adapt CM to ensure it is feasible and attractive to people who are seeking treatment for methamphetamine use disorder., (© 2023 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)

Background: There is no effective treatment for methamphetamine withdrawal. This study aimed to determine the feasibility and safety of a tapering dose of lisdexamfetamine for the treatment of acute methamphetamine (MA) withdrawal., Methods: Open-label, single-arm pilot study, in an inpatient drug and alcohol withdrawal unit assessing a tapering dose of oral lisdexamfetamine dimesylate commencing at 250 mg once daily, reducing by 50 mg per day to 50 mg on Day 5. Measures were assessed daily (days 0-7) with 21-day telephone follow-up. Feasibility was measured by the time taken to enrol the sample. Safety was the number of adverse events (AEs) by system organ class. Retention was the proportion to complete treatment. Other measures included the Treatment Satisfaction Questionnaire for Medication (TSQM), the Amphetamine Withdrawal Questionnaire and craving (Visual Analogue Scale)., Results: Ten adults seeking inpatient treatment for MA withdrawal (9 male, median age 37.1 years [IQR 31.7-41.9]), diagnosed with MA use disorder were recruited. The trial was open for 126 days; enroling one participant every 12.6 days. Eight of ten participants completed treatment (Day 5). Two participants left treatment early. There were no treatment-related serious adverse events (SAEs). Forty-seven AEs were recorded, 17 (36%) of which were potentially causally related, all graded as mild severity. Acceptability of the study drug by TSQM was rated at 100% at treatment completion. Withdrawal severity and craving reduced through the admission., Conclusion: A tapering dose regimen of lisdexamfetamine was safe and feasible for the treatment of acute methamphetamine withdrawal in an inpatient setting., Competing Interests: Conflict of interest LSA is supported by an NDARC PhD Scholarship. MF has received unrestricted funding for research purposes from Indivior and Sequiiris. SS has received clinical research supplies from Alkermes. NE and KJS are employed by NCCRED. No other investigators have any conflicts of interest to declare., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Introduction: Methamphetamine (MA) use disorder is an important public health concern. MA withdrawal is often the first step in ceasing or reducing use. There are no evidence-based withdrawal treatments, and no medication is approved for the treatment of MA withdrawal. Lisdexamfetamine (LDX) dimesilate, used in the treatment of attention deficit hyperactivity disorder and binge eating disorder has the potential as an agonist therapy to ameliorate withdrawal symptoms, and improve outcomes for patients., Methods: A single arm, open-label pilot study to test the safety and feasibility of LDX for the treatment of MA withdrawal. Participants will be inpatients in a drug and alcohol withdrawal unit, and will receive a tapering dose of LDX over five days: 250mg LDX on Day 1, reducing by 50mg per day to 50mg on Day 5. Optional inpatient Days 6 and 7 will allow for participants to transition to ongoing treatment. Participants will be followed-up on Days 14, 21 and 28. All participants will also receive standard inpatient withdrawal care. The primary outcomes are safety (measured by adverse events, changes in vital signs, changes in suicidality and psychosis) and feasibility (the time taken to enrol the sample, proportion of screen / pre-screen failures). Secondary outcomes are acceptability (treatment satisfaction questionnaire, medication adherence, concomitant medications, qualitative interviews), retention to protocol (proportion retained to primary and secondary endpoints), changes in withdrawal symptoms (Amphetamine Withdrawal Questionnaire) and craving for MA (visual analogue scale), and sleep outcomes (continuous actigraphy and daily sleep diary)., Discussion: This is the first study to assess lisdexamfetamine for the treatment of acute MA withdrawal. If safe and feasible results will go to informing the development of multi-centre randomised controlled trials to determine the efficacy of the intervention., Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Michael Farrell as Director of NDARC has received unrestricted funding for research purposes from Indivior and Sequiiris. Steve Shoptaw has received clinical research supplies from Alkermes. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Introduction: This study aimed to gather a range of opinions, including those of affected people (consumers, concerned others) to identify clinical research priorities for methamphetamine and emerging drugs of concern in Australia, to guide the work of the National Centre for Clinical Research on Emerging Drugs (NCCRED)., Methods: A priority setting study was conducted (February-March 2019) in four phases: online stakeholder survey, thematic analysis of responses, rapid literature review, expert panel ranking of priorities against predetermined criteria., Results: Forty-seven respondents completed the survey, including people identifying as one or more of: researcher (53%, n = 25), clinician (45%; n = 21), family/friend/caregiver of someone who uses methamphetamine/emerging drugs (15%, n = 7) and consumer of methamphetamine/emerging drugs (13%, n = 6). Expert panel, evidence-informed top-ranked clinical research priorities for methamphetamine were: strategies to overcome barriers to intervention uptake, pilot medication trials for adults seeking treatment, and communication strategies regarding evidence-based treatments. For emerging drugs of concern, top-ranked priorities were: piloting community-located drug checking, feasibility of social media/other opportunities to alert consumers of emerging risks, GHB overdose and withdrawal management, and impacts of an early warning information system on reducing harms., Discussion and Conclusions: We demonstrate feasibility of a structured, collaborative clinical research priority setting process. Results have informed the establishment of NCCRED; using the identified priorities to guide seed funding, fellowships/scholarships and research programs. Broader uptake of this methodology by policymakers/research funders would assist to embed areas of concern identified by affected communities and other stakeholders in research prioritisation., (© 2021 The Authors. Drug and Alcohol Review published by John Wiley & Sons Australia, Ltd on behalf of Australasian Professional Society on Alcohol and other Drugs.)

Background: In 2016, following a flurry of government inquiries and taskforces including calls for mandatory treatment regimes, the Australian community nominated methamphetamine as the drug most likely to be associated as a problem substance. Mandatory treatment for alcohol and other drug problems in Australia consists of broadly two mechanisms compelling a person into treatment: involuntary treatment or civil commitment regimes; and coercive treatment regimes, usually associated with the criminal justice system. This paper aims to provide a review of the evidence for mandatory treatment regimes for people who use methamphetamines., Methods: Using a narrative review methodology, a comprehensive literature and citation search was conducted. Five hundred two search results were obtained resulting in 41 papers that had cited works of interest., Results: Small, but robust results were found with coercive treatment programs in the criminal justice system. The evidence of these programs specifically with methamphetamine use disorders is even less promising. Systematic reviews of mandatory drug treatment regimes have consistently demonstrated limited, if any, benefit for civil commitment programs. Despite the growing popular enthusiasm for mandatory drug treatment programs, significant clinical and ethical challenges arise including determining decision making capacity in people with substance use disorders, the impact of self determination and motivation in drug treatment, current treatment effectiveness, cost effectiveness and unintended treatment harms associated with mandatory programs., Conclusion: The challenge for legislators, service providers and clinicians when considering mandatory treatment for methamphetamines is to proportionately balance the issue of human rights with effectiveness, safety, range and accessibility of both existing and novel mandatory treatment approaches.