To build scope & capacity for clinical research
New evidence based knowledge
Research into effective clinical practice
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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:
The register records:
The register will help the sector to:
The information provided comes directly from the Australian and New Zealand Clinical Trials Registry as of 7th October 2020. 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: email@example.com
Trial ID (Registry)
Date registered and status
Principal / Chief Investigator
Site / Location
Target sample size
Safety and Effect of Medical Cannabis on Relapse among 20 Patients with Methamphetamine Use Disorder: A Proof-of-Concept Trial
27 Aug 2020; HREC submitted, not yet approved; Not yet recruiting
Dr Stephen Bright +61 8 6304 2597 firstname.lastname@example.org
Medical Cannabis Research Australia
Medical Cannabis Research Australia / Edith Cowan University
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.
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
30 Jan 2020; HREC approved; Recruiting
A/Prof Victoria Manning +61 3 8413 8711 email@example.com
Victoria (postcodes 3128 - Box hill, 3004 - St Kilda Road Melbourne, 3145 - Malvern East)
National Centre for Clinical Research on Emerging Drugs
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.
INTEGRATE: An integrated treatment to decrease psychological distress and substance use in young people seeking help for emerging mental illness.
4 Nov 2019; HREC approved; Recruitment suspended
Dr Gillinder Bedi +61 3 9966 9435 firstname.lastname@example.org
Victoria (postcodes 3030 - Werribee, 3020 - Sunshine, 3046 - Glenroy, 3064 - Craigieburn)
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.
Feasibility and efficacy of the S-Check App: A harm reduction and early intervention smartphone application for methamphetamine use
3 Apr 2019; HREC approved; Not yet recruting
A/Prof Nadine Ezard +61 2 8382 1012 Nadine.Ezard@svha.org.au
ACT, NSW, NT, QLD, SA, TAS, WA, VIC
St Vincent's Hospital Sydney
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.
Novel Interventions to Address Methamphetamine Use in Aboriginal and Torres Strait Islander People (NIMAC). Phase 4: Effectiveness of a Culturally Appropriate Web-based Intervention
30 Jan 2019; HREC submitted, not yet approved; Not yet recruiting
A/Prof James Ward +61 439605277 email@example.com
NSW, NT, QLD, SA, WA, VIC
South Australian Health and Medical Research Institute
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
Characterising the effect of methamphetamine and alcohol on driving behaviour and performance in healthy volunteers
20 Apr 2018; HREC approved; Recruiting
Dr Amie Hayley +61 3 92145585 firstname.lastname@example.org
Swinburne University of Technology
The Jack Brockhoff and Edwina Flack Foundation
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.
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
13 Apr 2018; HREC approved; Recruitment suspended
Prof Gary Hulse +61 8 6457 2280 email@example.com
WA (Postcode 6008 - Subiaco)
Go Medical Industries Pty Ltd (Commercial)
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.
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
09 Mar 20148; HREC approved; Active, not recruiting
A/Prof Rebecca McKetin
NSW, VIC (Wollongong Hospital, Barwon Health Geelong Campus, Turning Point Drug and Alcohol Centre Fitzroy)
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).
An Evaluation of Holyoake's Methamphetamine Programs In Reducing Drug-Related Harms in Adults
15 Jun 2017; HREC approved; Active, not recruiting
Dr Robert Tait +61 8 9266 1610 firstname.lastname@example.org
Holyoake (Northam, Merredin, Narrogin, Moora)
WA Primary Health Alliance
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.
A randomised double blind placebo controlled study of lisdexamfetamine for the treatment of methamphetamine dependence (LiMA)
08 May 2017; HREC approved; Recruiting
A/Prof Nadine Ezard +61 2 8382 1036 email@example.com
NSW (SVH [Darlinghurst], Cumberland [Westmead], Newcastle West); SA (Adelaide [Stepney])
A/Prof Nadine Ezard
NHMRC, Curran Foundation
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.
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
4 Jan 2017; HREC approved; Recruitment suspended
Dr David McCutcheon +61 8 9224 2662 firstname.lastname@example.org
WA (Royal Perth Hospital)
Royal Perth Hospital
Royal Perth Hospital/Government body
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).
The effect of baclofen vs placebo on the activation of the mesolimbic dopaminergic system in methamphetamine dependent subjects: fMRI study.
22 November 2016; HREC approved; Recruiting
Dr Amanda Stafford +61 8 9224 1741 email@example.com
WA (Royal Perth Hospital)
Linear Clinical Research Ltd (commercial)
SHRAC Research Translation Project 2015 Grant (WA Department of Health)
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.
Feasibility, consumer acceptability and behavioural outcomes associated with take-home fentanyl test strips among people who use heroin
01 Sep 2020; HREC approved; Recruiting
Dr Rachel Sutherland +61 416779889 firstname.lastname@example.org
University of New South Wales
National Centre for Clinical Research on Emerging Drugs
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.