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Emerging drugs of concern clinical research register

A register of emerging drugs research being undertaken in Australia

Emerging drugs of concern clinical research register

Introduction

The National Centre for Clinical Research on Emerging Drugs (NCCRED) aims to enhance Australia’s clinical capacity to respond to emerging drugs of concern by further developing current and future workforces responsible for initiating, undertaking and implementing relevant clinical research in the field.

Presently, there is little overview of clinical research into emerging drugs currently being undertaken in Australia. NCCRED has collated trials registered with the Australian and New Zealand Clinical Trials Registry (ANZCTR), and relevant groups/networks listed under the National Clinical Trials Alliance.

The register reflects current clinical trials underway in Australia, related to emerging drugs of concern, and addressing issues ranging from early intervention through to tertiary interventions focused on problems such as withdrawal and dependence. It covers the following emerging drugs and related health related problems:

  • Methamphetamine
  • Amphetamine-Related Disorders
  • Substance-related disorders
  • Psychotropic (drugs)
  • Illicit (drugs)
  • Novel Psychoactive substances

The register records:

  • Nature of research (e.g. clinical trials, clinical quality enhancement projects, analysis of data from routine data sources)
  • Institutions involved
  • Researchers involved
  • Research approaches being used
  • Extent and nature of consumer and clinician involvement in the research
  • Sources of funding

The register will help the sector to:

  • Improve knowledge and sharing of information concerning emerging drugs clinical research being undertaken in Australia
  • Identify priorities for future types (as opposed to topics) of research (e.g. clinical trials, clinical quality enhancement projects, analysis of data from routine data sources)
  • Identify workforce skills required to undertake these types of research
  • Develop recommendations and approaches to address identified research skill gaps

Please note

The information provided comes directly from the Australian and New Zealand Clinical Trials Registry as of 29th June 2021. Some studies which are displayed as Active on the ANZCTR may not have been updated within the previous 12 months.

Any suggestions on how to improve this register would be welcomed – please contact the NCCRED Knowledge Translation Lead: florence.bascombe@nccred.org.au

Emerging drugs of concern clinical research register

Title

Notes

Sponsor

Funding (details)

Site / Location

Principal / Chief Investigator

Trial ID (Registry)

Date registered and status

Target sample size

An open-label, safety and feasibility pilot study of tapering lisdexamfetamine for adult methamphetamine withdrawal inpatients (OLAM)

This trial is an open-label, single-arm safety and feasibility trial of lisdexamfetamine for the management of acute methamphetamine withdrawal. Participants presenting for inpatient management of methamphetamine withdrawal will receive a tapering dose of lsidexamfetamine, starting at 250mg on day 1, reducing by 50mg per day to 50mg on day 5. Participants will be encouraged to remain in treatment for another two days for ongoing monitoring and will be followed up weekly for three weeks post discharge. We hypothesise that lisdexamfetamine is safe and feasible for the management of acute methamphetamine withdrawal.

St Vincent's Hospital Sydney

National Centre for Clinical Research on Emerging Drugs

NSW

Mr Liam Acheson +61290657809 liam.acheson@svha.org.au

18/01/2021; HREC Approved; Recruiting

15

The effect of baclofen vs placebo on the activation of the mesolimbic dopaminergic system in methamphetamine dependent subjects: fMRI study. (fMRI)

Methamphetamine addiction is a major and growing problem in Australia, with a considerable individual, family and community burden. The current trend is a rapid increase in the use of crystal methamphetamine, the most addictive form, from 10% of users in 2010 to over 50% in 2014. Current treatment options for methamphetamine addiction are all based on Cognitive Behavioural Therapy (CBT) and have very low rates of durable abstinence. There are no proven pharmacotherapy options to assist in attaining and maintaining abstinence. The rapid increase in the use of high purity, highly addictive forms of methamphetamine, coupled with a lack of effective treatment, portends a public health catastrophe in Australia as outlined in the National Ice Action Strategy announced in April 2015.
The key focus of treatment is to stop addicted individuals succumbing to the intense drug cravings on exposure to “drug cues”: anything that evokes drug memories eg places or people associated with their methamphetamine use. The treatments based on CBT aim to alter the individual’s response to drug cues but the igniting of these intense cravings is outside of conscious control. A more effective treatment strategy is to weaken the intensity of drug cravings with anti-craving medication.
Baclofen is a strong candidate for methamphetamine addiction treatment due to its proven effectiveness in suppressing drug cravings for cocaine, another stimulant drug which, like methamphetamine, acts via the dopamine reward pathways of the brain. A 2014 study on cocaine addiction used functional MRI (fMRI) to objectively study the brain activation patterns in cocaine addicts in response to cocaine associated images (drug cues). The subjects treated with baclofen showed a dramatic and specific suppression of activation of the brain’s reward pathways compared to the placebo group. This provides a mechanistic explanation for the clinical effectiveness of baclofen in suppressing cravings for and the use of cocaine in addicted individuals. The study proposed in this application will reproduce the fMRI/cocaine study in 18 methamphetamine addicted subjects to test the effectiveness of baclofen (vs placebo) in suppressing reward pathway activation in response to methamphetamine drug cues. If baclofen is effective, it would provide the foundation for clinical trials of baclofen therapy combined with standard CBT treatment for methamphetamine addiction.
This study seeks to rapidly establish if baclofen has an anti-craving action in the methamphetamine addicted brain. A positive result will accelerate baclofen treatment being adopted into current treatment programs for methamphetamine addiction with the aim of increasing durable abstinence rates.

Linear Clinical Research Ltd (commercial)

SHRAC Research Translation Project 2015 Grant (WA Department of Health)

WA (Royal Perth Hospital)

Dr Amanda Stafford +61 8 9224 1741 amanda.stafford@health.wa.gov.au

22 November 2016; HREC approved; Recruiting

18

Methamphetamine use in young people: safety and tolerability of Sub-anaesthetic Ketamine, An Open-label Trial (MASKOT)

Low-dose ketamine, administered subcutaneously by a study clinician (medical doctor or nurse) once a week for 2 weeks. The starting dose (Level 1) of ketamine is 0.75mg/kg, followed by the second dose (0.9mg/kg; Level 2) after at least 7 days, if participants are able to tolerate the initial dose without clinically significant discomfort. Those who are unable to tolerate the starting dose (Level 1) will have their dosage reduced to 0.6mg/kg (Level 0) for the second dose administration. Medication administration and missed administration sessions will be recorded on study documentation.

Orygen National

National Centre for Clinical Research on Emerging Drugs

Victoria

A/Prof Gillinder Bedi +61466247270 gill.bedi@orygen.org.au

05/05/2021; HREC Approved; Not yet recruiting

20

Safety and Effect of Medical Cannabis on Relapse among 20 Patients with Methamphetamine Use Disorder: A Proof-of-Concept Trial

The primary objective of this open-label matched control trial is to examine the safety and efficacy of enriched CBD oil for reducing relapse among people accessing treatment for methamphetamine use disorder. The effect of enriched CBD oil on depression, anxiety and sleep will also be evaluated.

Medical Cannabis Research Australia

Medical Cannabis Research Australia / Edith Cowan University

Western Australia

Dr Stephen Bright    +61 8 6304 2597 s.bright@ecu.edu.au

27 Aug 2020; HREC submitted, not yet approved; Not yet recruiting

20

Characterising the effect of methamphetamine and alcohol on driving behaviour and performance in healthy volunteers (MeAD)

Amphetamine-type substances, especially d-methamphetamine, are second only to alcohol for incurred personal, economic and societal burden. Both alcohol and methamphetamine produce impairments in many areas of cognitive/neurobehavioural functioning which are also observed under complex driving conditions, and these two drugs are detected in as many as one-third of drivers injured and killed in road traffic accidents. No controlled experimental research is available which assesses performance on these tasks when alcohol and methamphetamine are used in combination, and importantly, how these deficits may translate into increased crash risk.
This trial aims to assess the direct effect of combined usage of low (legal) doses of alcohol combined with d-methamphetamine in measures of higher-order cognitive and neurobehavioural functioning, driving performance and ocular activity. This will be achieved through a within-subjects, double-blind, placebo-controlled design comprising four experimental sessions [alcohol (placebo: 0.00% BAC; active: 0.04% BAC) and d-methamphetamine (0.42mg/kg, placebo; active).
This project will provide vital information of how several behavioural, cognitive, neurobehavioural and physiological indices are affected following combined
alcohol and methamphetamine use, and will show the effect of these combined drugs on driving performance and accident risk.

Swinburne University of Technology

The Jack Brockhoff and Edwina Flack Foundation

Victoria

Dr Amie Hayley   +61 3 92145585  ahayley@swin.edu.au

20 Apr 2018; HREC approved; Recruiting

30

Determining the feasibility and efficacy of Goal Management Training for executive functions, and treatment retention and outcomes during residential treatment for methamphetamine use disorder (GMT4MA)

Recovery following current treatment for methamphetamine use disorder (MUD) is poor. Only 14% of individuals report continued abstinence at one-year follow-up, which decreases again to 6% after three years. One of the critical limitations of existing treatment approaches is that they do not address the cognitive deficits that result from long-term methamphetamine use, which is critical to recovery from methamphetamine addiction. We intend to conduct a proof of concept trial to test GMT+ within a residential addiction rehabilitation setting for individuals with MUD. Participants will receive follow-up testing immediately after the intervention (cognitive performance, acceptability), 4-weeks after the intervention (treatment retention, quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence), and 12-weeks after the intervention (quality of life, impulsivity, severity of dependence, reduced methamphetamine use or abstinence) to assess the benefit of GMT+ compared to psychoeducation-control

Monash University

National Centre for Clinical Research on Emerging Drugs

Victoria

Prof Antonio Verdejo-Garcia +61399055374 antonio.verdejo@monash.edu

08/02/2021; HREC Approved; Not yet recruiting

48

A randomised (non-blinded) trial comparing the clinical efficacy of naltrexone implant plus Cognitive Behavioral Therapy versus Cognitive Behavioral Therapy in the management of problem amphetamine use

The study aims to investigate whether treatment with long-acting naltrexone implant (OLANI) as well as counselling is more effective than just counselling for preventing relapse to regular amphetamine use. Additionally, we are investigating the effect of naltrexone implant treatment on utilisation of WA Health Services (Hospital admissions, Emergency Department presentations and Mental Health services) in order to assess cost savings and cost effectiveness.

Go Medical Industries Pty Ltd (Commercial)

Government body

WA (Postcode 6008 - Subiaco)

Prof Gary Hulse    +61 8 6457 2280 gary.hulse@uwa.edu.au

13 Apr 2018; HREC approved; Recruitment suspended

60

Feasibility, consumer acceptability and behavioural outcomes associated with take-home fentanyl test strips among people who use heroin

The primary aim of this project is to examine the feasibility, consumer acceptability and behavioural outcomes associated with take-home fentanyl test strips (FTS), providing an evidence base for implementation and expansion across services in Australia.
People who use heroin (n=80) will be trained in how to use FTS to test their heroin (or other illicit substances) for the presence of fentanyl, and how to interpret the results, Upon completion of the training, participants will complete a short baseline survey, and be given ten strips to take home and use as they wish. Participants will be followed-up four weeks later to assess uptake and consumer acceptability of the strips, as well as associated behavioural changes.

University of New South Wales

National Centre for Clinical Research on Emerging Drugs

NSW

Dr Rachel Sutherland  +61 416779889  rachels@unsw.edu.au

01 Sep 2020; HREC approved; Recruiting

80

A pilot randomised controlled trial (RCT) testing the effect of personalised approach bias modification (vs. sham training) on abstinence from methamphetamine following discharge from rehabilitation in patients undergoing residential treatment for methamphetamine use disorder (MAAT)

Approximately half of those attending residential rehabilitation for methamphetamine use disorder (MUD) use methamphetamine within 3-months of leaving rehabilitation. One factor associated with relapse following residential treatment is “approach bias” – easily-triggered impulses to approach drug-related stimuli, and to seek drugs in response to these stimuli. Approach bias develops after frequent drug use, but studies in people with alcohol use disorders (including our own research) suggest that approach bias can be reduced through computerised training known as “approach bias modification” (ABM), which also reduces likelihood of relapse. However, aside from our small open-label feasibility study with methamphetamine withdrawal patients, this approach has not been trialed in people seeking treatment for MUD. Moreover, the approach of seeking to increase the efficacy of ABM by personalising the stimuli used in ABM training (e.g. to match the specific forms of drugs and route of administration that individual clients use), has not been trialed for any substance so far. We intend to commence a pilot RCT to test a 2-week course of personalised ABM (3 sessions per week). Patients with MUD will be randomised to receive either personalised ABM or a sham training control condition. Participants will be followed up 1- and 3-months post-discharge from rehabilitation to determine whether personalised ABM reduces methamphetamine use, craving, MUD symptoms, and methamphetamine approach bias, relative to patients who receive “sham” training.

Study Website link (Turning Point)

Monash University

National Centre for Clinical Research on Emerging Drugs

Victoria (postcodes 3128 - Box hill, 3004 - St Kilda Road Melbourne, 3145 - Malvern East)

A/Prof Victoria Manning   +61 3 8413 8711 victoria.manning@monash.edu

30 Jan 2020; HREC approved; Recruiting

100

An Evaluation of Holyoake's Methamphetamine Programs In Reducing Drug-Related Harms in Adults

The study aims to evaluate an evidence based approach to the design of a new treatment service for users of methamphetamine. Traditionally, services were designed for heroin or alcohol using clients who have different treatment needs and problems to methamphetamine users. Holyoake will implement an intensive case management model including medical, peer and family support for methamphetamine users at one site (Northam) but will offer its standard service at other regional sites (Narrogin and Merredin). We will compare outcomes for the new and standard programs (target to recruit 120 people in total) in terms of changes in substance use, mental health, wellbeing and social indicators (i.e. employment and housing status). Participants will be followed up by telephone at 4 weeks and 6 months and by record linkage at 12 months. We hypothesize that those receiving the intensive intervention will show greater improvement in key measures that the standard care group. We also plan telephone interviews with a close family member (e.g. partner, parent) to evaluate improved wellbeing for that person. 

Curtin University

WA Primary Health Alliance

Holyoake (Northam, Merredin, Narrogin, Moora)

Dr Robert Tait +61 8 9266 1610 robert.tait@curtin.edu.au

15 Jun 2017; HREC approved; Active, not recruiting

120

The N-ICE trial: A randomised controlled trial of the safety and efficacy of N-Acetyl Cysteine (NAC) as a pharmacotherapy for methamphetamine ('ice') dependence (N-ICE)

We will test the safety and efficacy of N-Acetyl-Cysteine (NAC) as a pharmacotherapy for methamphetamine dependence using a double-blind placebo-controlled randomised controlled trial (RCT). The trial will involve 180 participants receiving either 12 weeks of take-home oral NAC (2,400 mg daily) or equivalent placebo. There are three trial sites (Wollongong, Geelong and Melbourne). This is a Phase 2b trial that is powered to confirm whether NAC has a clinically relevant benefit on methamphetamine use and a range of related clinical outcomes. Primary hypothesis: Daily oral NAC delivered as a take home medication will reduce methamphetamine use measured as (a) days of methamphetamine use, and (b) methamphetamine in weekly saliva tests, during 12 weeks of active treatment relative to placebo. Secondary hypotheses: Daily oral NAC delivered as a take home medication will, relative to placebo: - reduce the severity of methamphetamine dependence, craving for methamphetamine, methamphetamine withdrawal symptoms and psychiatric symptoms (affective symptoms, positive psychotic symptoms and hostility), - have an acceptable adverse event profile, and - not significantly increase the use of other substances (including alcohol, tobacco, cannabis, heroin and cocaine).

Curtin University

NHMRC

NSW, VIC (Wollongong Hospital, Barwon Health Geelong Campus, Turning Point Drug and Alcohol Centre Fitzroy)

A/Prof Rebecca McKetin  
+61 8 9266 1602 rebecca.mcketin@curtin.edu.au 

09 Mar 20148; HREC approved; Active, not recruiting

180

A randomised double blind placebo controlled study of lisdexamfetamine for the treatment of methamphetamine dependence (LiMA)

Australia has one of the highest rates of methamphetamine dependence in the world. While counselling is effective for many people with less severe dependence, there is no proven medication treatment for severe dependence. Lisdexamfetamine is a stimulant of the brain and is approved in Australia for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is a once-daily oral medication converted to dexamphetamine in the blood. The aim of the LiMA study is to test if lisdexamfetamine is effective in reducing methamphetamine use, cravings and withdrawal symptoms in people who are dependent on methamphetamine. This will be a randomised double-blind placebo-controlled study which means that one group will receive lisdexamfetamine and another will receive a placebo (a medication with no active ingredients), in addition to counselling. Participants, clinicians and researchers involved in the study will not know to which group they have been allocated. The two groups will be compared and the findings will contribute to evidence for the future use of lisdexamfetamine in the treatment of methamphetamine dependence.180 people will be recruited to the LiMA study which will be conducted in specialist treatment centres in Sydney, Newcastle and Adelaide. It is anticipated that recruitment will start in early 2017. 

St Vincent's Hospital Sydney

NHMRC, Curran Foundation 

NSW (SVH [Darlinghurst], Cumberland [Westmead], Newcastle West); SA (Adelaide [Stepney])

A/Prof Nadine Ezard +61 2 8382 1036 nadine.ezard@svha.org.au

08 May 2017; HREC approved; Recruiting

180

Novel Interventions to Address Methamphetamine Use in Aboriginal and Torres Strait Islander People (NIMAC). Phase 4: Effectiveness of a Culturally Appropriate Web-based Intervention

Methamphetamine use is of deep concern in Aboriginal and Torres Strait Islander communities but access to culturally appropriate treatment resources and services is limited. The 'We Can Do This' web-based therapeutic intervention (WBTI) is designed to incorporate evidence-based therapies in a culturally-relevant format using narratives from Aboriginal people to contextualise the therapeutic content. The effectiveness of the WBTI will be tested in a wait-list control, randomised trial across multiple sites in urban, regional and remote locations. Participants will be Aboriginal and Torres Strait Islander people aged 16 or over recruited online and via health services. The primary outcome measure will be the number of days when the participant used methamphetamine during the treatment phase. Secondary outcomes will include readiness to change, help-seeking, severity of dependence, psychological distress and health service access. Assessment will occur at baseline, 1 month, 2 months and 3 months. If successful, the ‘We Can Do this’ WBTI will increase the range of options available to Aboriginal people seeking to reduce or stop methamphetamine use. It will provide health practitioners with a culturally-appropriate, evidence-based resource to use with clients, and may provide a pathway into treatment for people who may otherwise be disengaged with health services for a range of reasons

South Australian Health and Medical Research Institute

Government body

NSW, NT, QLD, SA, WA, VIC

A/Prof James Ward   +61 439605277  james.ward@sahmri.com

30 Jan 2019; HREC submitted, not yet approved; Not yet recruiting

288

INTEGRATE: An integrated treatment to decrease psychological distress and substance use in young people seeking help for emerging mental illness.

The aim of the study is to test whether a new integrated psychological treatment (INTEGRATE) improves mental health difficulties and decreases the risk of problematic substance use in young people, compared with usual treatment.

Young people between the ages of 12 and 25 (inclusive) will be randomised to receive either i) the INTEGRATE therapy, or ii) treatment as usual (TAU), for 16 weeks in a double-blind, randomised controlled trial (RCT), with followup to 18 months.
The primary hypothesis is that young people who are randomised to receive the INTEGRATE intervention will decrease their alcohol and other drug use compared to participants in the TAU group.

Gandel Philanthropy

Orygen

Victoria (postcodes 3030 - Werribee, 3020 - Sunshine, 3046 - Glenroy, 3064 - Craigieburn)

Dr Gillinder Bedi   +61 3 9966 9435 gill.bedi@orygen.org.au

4 Nov 2019; HREC approved; Recruitment suspended

400

Western Australian Illicit Substance Evaluation - assessing blood levels and types of illicit substances in patients suspected to be intoxicated with stimulant or hallucinogenic drugs in the emergency department (WISE)

Recreational drug use is becoming an increasing public health issue in our society. Methamphetamine usage in Australia has been described as an ‘epidemic’ that is ‘tearing our country apart’, and has recently been the subject of a Prime Ministerial National Ice Task Force. The average purity of methamphetamine seized by police in Western Australia has increased from 10% to 75% in just six years. In addition to this, there are a huge new range of synthetic drugs entering circulation, which are collectively termed novel psychoactive substances. These include many novel stimulants and hallucinogens, such as cathinones, NBOMe type drugs, and synthetic cannabinoid receptor antagonists. There were seven unrelated deaths in Australia over the 2015-2016 summer festival season related to synthetic drug use, as publicised in the ABC Four Corners investigation “Dying to Dance” (February 2016).

This project is a novel study, based in the emergency department (ED), where patients suspected of being under the influence of recreational drugs have a single blood sample taken to identify the causative agent. The analysis will be undertaken by ChemCentre WA, with whom we have an established collaboration, using liquid chromatography-mass spectrometry analytical techniques. Prior to analysis, the sample is permanently de-identified. We aim to identify the agent (or agents), determine its concentration, and relate it to the clinical picture and complications. We will also compare the analytic result with what the patient believed they had taken.

Where novel drugs are identified, repeat analytical work can be undertaken to aim to develop new assays and reference standards for future analysis. Samples will be stored frozen for five years to enable this work. We will be able to identify trends in recreational drug use in patients presenting to the ED, which is vitally important from a public health perspective. Should information of early interest to clinicians or the general public be identified, this would be released in the interest of public safety.

Royal Perth Hospital

Royal Perth Hospital/Government body

WA (Royal Perth Hospital)

Dr David McCutcheon   +61 8 9224 2662  david.mccutcheon@health.wa.gov.au

4 Jan 2017; HREC approved; Recruitment suspended

600

Feasibility and efficacy of the S-Check App: A harm reduction and early intervention smartphone application for methamphetamine use (S-Check App)

The S-Check App has been developed as a self-administered smartphone based harm reduction and early intervention application for those who use methamphetamine. The S-Check App will be provide the user with information to manage their methamphetamine use and support services available, should they need to seek help. One group will be randomize to have immediate access to the App for 28 days while the one group will be randomize to have delayed access to the App 28 days later. Both groups will be asked to complete a surveys at the start and 28 days to assess whether there has been any behavioral change in their methamphetamine use.
Frequency and use of the features of the App will be at the discretion of the participant for the 28 days that they will have access to the App. The App has several sections, such as physical health, social health and psychological well being. The participant will be able to enter information into these sections and the App will be able to provide advice based on the associated risk of the information supplied. The App also has a diary section, where the participant can write and upload videos, audio and pictures to seek track of their progression. They will be awarded achievement badges upon completion of each section of the App. Internal metrics will capture which sections of the App are used, the frequency and the duration of App use. This information together with the surveys will assist the study team in determining the efficacy and feasibility of the App as a harm reduction and early intervention tool.

S-Check App website

St Vincent's Hospital Sydney

Government body

ACT, NSW, NT, QLD, SA, TAS, WA, VIC

A/Prof Nadine Ezard    +61 2 8382 1012   Nadine.Ezard@svha.org.au

3 Apr 2019; HREC approved; Not yet recruting

1020