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Clinical Research Projects

Current research projects

OLAM Study

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

This study examines a tapering dose of lisdexamfetamine in addition to treatment as usual in a population of adults being treated for methamphetamine withdrawal in an inpatient setting. We will recruit 15 people for a 7-day inpatient open-label safety and feasibility study with weekly follow up for 3 weeks post discharge. Participants will receive 250mg of lisdexamfetamine on day 1 of their admission tapered by 50mg per day to 50mg on day 5. Days 6 and 7 are medication free to monitor for withdrawal symptoms and ensure participants are stimulant free upon discharge. The primary outcome is safety and feasibility with secondary outcomes of acceptability, retention in treatment, withdrawal symptoms and craving, and effects on sleep.

Dr Krista Siefried

UNSW/National Centre for Clinical Research on Emerging Drugs

Prof Nadine Ezard

SVHS/UNSW/National Centre for Clinical Research on Emerging Drugs

Prof Adrian Dunlop

Hunter New England LHD/Drug and Alcohol Clinical Services

Prof Nicholas Lintzeris

South East Sydney LHD/Drug and Alcohol Services

Dr Jonathan Brett

SVHS/Alcohol and Drug Service/Clinical Pharmacology and Toxicology

Liam Acheson

SVHS/UNSW/Alcohol and Drug Service/National Drug and Alcohol Research Centre

Dr Craig Rodgers

SVHS/Alcohol and Drug Service

Dr Anthony Gill

SVHS/Alcohol and Drug Service

Prof Michael Farrell

UNSW/National Drug and Alcohol Research Centre

A/Prof Rebecca McKetin

UNSW/National Drug and Alcohol Research Centre

Dr Michael Christmass

Next Step Drug and Alcohol Services/Drug and Alcohol Services

Prof Steve Shoptaw

The University of California, Los Angeles/Family Medicine/Psychiatry and Biobehavioural Sciences


SUSI

The Substance Use and Sex Index (SUSI) addresses a lack of tools for measuring transmission-risk behaviours alongside HIV treatment and prevention innovations, and the context of drug use such as “chemsex” / “party and play”

Neither substance use nor sexual behaviour is inherently ‘risky’, but we do know that there is some relationship with transmission of HIV, sexually transmitted infections (STIs) and other blood-borne viruses (BBVs). We therefore need to make sure we have a way to effectively measure risk behaviours.

The Substance Use and Sex Index (SUSI) seeks to address these issues and has been developed by a group of researchers at The University of Tasmania, The University of NSW and The University of Sydney. An advisory group made up of Australian community experts and clinicians provides expertise and guidance over the tool’s development. Version 1 of the tool was piloted in 2016 as an anonymous online questionnaire. Based on feedback and review of the piloted tool, version 2 is an online questionnaire to be completed anonymously.

The new SUSI tool will provide a more effective way of measuring risk behaviours compared with tools that are currently in use. SUSI has the potential to support the effective treatment of substance use disorders as well as support effective prevention, treatment and care relating to HIV, STIs and BBVs. If you would like further information on the study, or would like to participate, go to the SUSI website by clicking here. (Approved by St Vincent’s Hospital Sydney Human Research Ethics Committee, reference number: LNR/18/SVH/31; and the ACON Research Ethics Committee reference number: 2018/02)

Prof Nadine Ezard

SVHS/UNSW/National Centre for Clinical Research on Emerging Drugs

Beatrice Webb

School of Medicine, University of Tasmania

Brendan Clifford

SVHS / Sydney Nursing School, University of Sydney

Michael E. Cecilio

Alcohol & Drug Service, St Vincent’s Hospital Sydney

Amanda Jellie

School of Medicine, Sydney, University of Notre Dame

Toby Lea

German Institute for Addiction and Prevention Research (DISuP), Catholic University of Applied Sciences, North Rhine-Westphalia

Dr Craig Rodgers

SVHS/Alcohol and Drug Service

Simon Ruth

Victorian AIDS Council

Prof Raimondo Bruno

School of Medicine, University of Tasmania


LiMA Study

A double-blind randomised controlled trial to evaluate the efficacy of lisdexamfetamine in reducing methamphetamine use

 

The aim of The LiMA Study is to test if lisdexamfetamine is effective in reducing methamphetamine use, cravings and withdrawal symptoms. 180 people with methamphetamine dependence will be recruited to the LiMA Study, which will be conducted in specialist treatment centres in Sydney, Newcastle, Adelaide and Melbourne. Participants will be randomly assigned to receive either a 15-week intervention consisting of induction (1 week of 150mg lisdexamfetamine [LDX] or placebo), maintenance (12 weeks of 250mg LDX or placebo) and reduction (1 week of 150mg LDX or placebo and 1 week of 50mg LDX or placebo). All participants will be given access to 4 sessions of Cognitive Behaviour Therapy (CBT) as treatment-as-usual and receive a 4-week follow up appointment. A full protocol for the study has been published here.

The LiMA study is currently recruiting in Sydney, Newcastle, Melbourne and Adelaide. If you or someone you know would like further information about the study please visit the website to contact the research coordinator closest to you. This study has been approved by the Human Research Ethics Committee of St. Vincent’s Hospital, Sydney, Australia (HREC/16/SVH/222).

Prof Nadine Ezard

SVHS/UNSW/National Centre for Clinical Research on Emerging Drugs

Prof Adrian Dunlop

Hunter New England LHD/Drug and Alcohol Clinical Services

Michelle Hall

Drug and Alcohol Clinical ServicesHunter New England 

A/Prof Robert Ali

UNSW / University of Adelaide

Prof Raimondo Bruno

School of Medicine, University of Tasmania

A Prof Rebecca McKetin

Curtin UniversityPerthWestern Australia / NDARC / UNSW

Dr Nghi Phung

Western Sydney Local Health DistrictSydney

Prof Andrew Carr

Alcohol and Drug Service, St Vincents Hospital, Sydney / University of New South Wales

Jason White

University of South Australia

Brendan Clifford

SVHS / Sydney Nursing School, University of Sydney

Dr Xhixin Liu

UNSW

Marian Shanahan

National Drug and Alcohol Research Centre, UNSW Sydney

Prof Kate Dolan

National Drug and Alcohol Research Centre, UNSW

Prof Amanda L. Baker

School of Medicine and Public HealthUniversity of Newcastle

Prof Nicholas Lintzeris

University of Sydney/South East Sydney LHD/Drug and Alcohol Services

 


Clinical Research Priority Study

Setting the research priorities for NCCRED

To focus the clinical research efforts of the Centre, the NCCRED priority setting study (2019) engaged nationally with key alcohol and other drug clinical, research, and consumer stakeholders in Australia to determine clinical research priorities. The study undertook the guidance provided in the Nine Common Themes of Good Practice, a published checklist for guiding research priority setting procedures. These are: context; comprehensiveness of approach; inclusiveness; information gathering; planning for implementation; criteria; methods for deciding on priorities; evaluation; transparency.

The study consisted of four phases: 1) an online survey of stakeholders; 2) a qualitative thematic analysis (assessment of survey responses); 3) a brief literature review assessing the themes identified by respondents against published peer-reviewed data, and; 4) presentation of all results and literature reviews to an independent expert panel. The NCCRED Methamphetamine and Emerging Drugs Clinical Research Network working group functioned as the expert panel. Results were ranked, and the top three priorities for methamphetamine clinical research and the top three priorities for emerging drugs clinical research were presented to NCCRED and the NCCRED Board.

For methamphetamine:

  • Overcoming barriers to intervention uptake (e.g at time of crisis in emergency departments or primary health care)
  • Pilot pharmacotherapy trials for adults seeking treatment
  • Effective communication strategies for consumers on available treatments and the evidence-based options

For emerging drugs:

  • Fixed-site community-located drug checking / pill testing (connected to an early warning system)
  • Feasibility of social media and other creative opportunities to alert consumers and reduce harm
  • GHB overdose and withdrawal management
  • Early warning system / shared information – pooling and sharing information and assessing the impact of reducing harm

Dr Krista Siefried

UNSW/National Centre for Clinical Research on Emerging Drugs

Quoc Nguyen

UNSW/National Centre for Clinical Research on Emerging Drugs

Prof Nadine Ezard

SVHS/UNSW/National Centre for Clinical Research on Emerging Drugs

A/Prof Robert Ali

UNSW / University of Adelaide


BWUM

Barriers to stimulant treatment access for women who use methamphetamine in inner Sydney: a qualitative study

Methamphetamine use can lead to a wide variety of complex physical, psychological and social problems. Globally, women are under-represented in treatments for substance use disorders, making up a third of those who use drugs, but only a fifth of those in treatment.  Specialist treatment programs which provide non-judgmental harm minimisation and risk stratification are increasing, but little is known on whether women have appropriate access to such services or if there are specific needs which should be addressed to encourage engagement. There is a lack of qualitative research into the gendered experiences of women who access services for methamphetamine, and the potential barriers to treatment. In this study, the experiences of women who were frequent (at least weekly) users of methamphetamine, but were not engaged in treatment were explored. 11 semi-structured interviews were conducted at four sites in inner Sydney with women who use methamphetamine. Interviews were recorded, transcribed verbatim, and continued until saturation had been reached. Thematic analysis using Nvivo® software is now being carried out.

Ethics approval for the study was granted by the Human Research Ethics Committee of St. Vincent’s Hospital, Sydney (Approval LNR/15/SVH/469).

Brendan Clifford

SVHS / Sydney Nursing School, University of Sydney

Prof Nadine Ezard

SVHS/UNSW/National Centre for Clinical Research on Emerging Drugs

Dr Kathryn Van Gordon

SVH

Krista Siefried

UNSW/National Centre for Clinical Research on Emerging Drugs

Duncan Graham

UNSW/National Centre for Clinical Research on Emerging Drugs

Fiona Magee

Victoria Malone

 

Completed research

Lisdex Pilot

Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study

Background: Methamphetamine (MA) dependence is a growing global health issue with no effective pharmacotherapy. Lisdexamfetamine (LDX) is approved for use in the treatment of attention-deficit/hyperactivity disorder (ADHD) and binge eating disorder (BED) in doses ranging from 30 to 70mg/day. LDX has a longer duration of action and lower abuse potential than other amphetamines, and presents a promising candidate for agonist-type treatment of MA dependence. People seeking treatment for MA dependence may require doses of LDX higher than used in ADHD and BED. We examined the safety of LDX at 250mg/day among adults with MA dependence, approximately equivalent to previously trialled doses of dexamphetamine.

Methods: We conducted a dose-escalating, phase-2, open label, single-group study of oral LDX at two Australian drug treatment services. Eligible participants were MA dependent adults who reported use of MA on at least 14 of the preceding 28 days. Once daily, supervised LDX doses of 100 to 250mg/day were provided as a single-blinded, ascending-descending dose regimen over 8 weeks. The primary outcomes were safety, drug tolerability, and regimen completion at the end of Week 4 (maximum dose). Participants were followed through to Week 12. Secondary outcomes included: change in MA use; craving; withdrawal; severity of dependence; risk behaviour; change in other substance use; medication acceptability; potential for non-prescription use; adherence; and neurocognitive functioning.

Results: Fourteen of 16 participants (87.5%) successfully completed the four week escalation regimen to 250mg/day. Two participants withdrew from the trial in the first week. No participant was withdrawn due to adverse events. MA use decreased significantly (p=0.013) from a median of 21 days (IQR: 16-23) to 13 days (IQR: 11-17) over the four week escalation period.

Conclusions: LDX at a dose of up to 250 mg/day was safe and well tolerated in this population, with high retention. Larger trials of LDX as a pharmacotherapy for MA dependence are warranted.

Trial Registration : Australian and New Zealand Clinical Trials Registry ACTRN12615000391572.

Nadine Ezard
St Vincent’s Hospital Sydney
Brendan Clifford
St Vincent’s Hospital Sydney
Adrian Dunlop
Hunter New England Local Health District & University of Newcastle
Raimondo Bruno
University of Tasmania
Andrew Carr
St Vincent’s Hospital Sydney
Zhixin Liu
St Vincent’s Hospital Sydney
Krista Siefried
University of New South Wales
Nicholas Lintzeris
The University of Sydney

Published research

Siefried KJ, et al. Pharmacological Treatment of Methamphetamine/Amphetamine Dependence: A Systematic Review.

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Ezard N, et al. LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence.

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Brener L, et al. Providing a model of health care service to stimulant users in Sydney.

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Ezard N, et al. Substance Use and Sex Index (SUSI): First stage development of an assessment tool to measure behaviour change in sexualised drug use for substance use treatment studies.

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Ezard N, et al. Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence.

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Conference presentations and abstracts

  • Acheson LS; Murray E; Clifford B; Siefried KJ; Matthews GV; Ezard N. ‘Optimising care for people who inject drugs: A retrospective medical record review of staphylococcus aureus bactaraemia treatment’, in Drug and Alcohol Review, Wiley, Hobart, Australia, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Hobart, Australia, 10 – 13 November 2019, http://dx.doi.org/10.1111/dar.12991, ROS ID: 1505720
  • Bruno R, Leicester O, Acheson L, Malone V, Clifford B, Siefried K, Rodgers C, Ezard N. Substance Use and Sex Index (SUSI): Validation of a behaviour change assessment tool. Poster, APSAD, Hobart, Australia 10 – 13 November 2019
  • Ezard N. ‘New Directions in the treatment of methamphetamine use disorder’ NDARC Annual Symposium, Sydney Australia 2019 Available here
  • Ezard N. Keynote Speaker, ‘Responding to emerging drugs of concern in Australia’ APSAD, Hobart, Australia 2019
  • Black E; Deacon RM; Mills L; Dunlop A; Ezard N; Bruno R; Shakeshaft A; Farrell M; Holmes J; Cretikos MA; Montebello M; Reid D; Childs S; Siefried KJ; Mammen K; Lintzeris N. ‘Characteristics and treatment outcomes of the drug treatment population in New South Wales: Focus on amphetamine type stimulants’, in Drug and Alcohol Review, Wiley, Hobart, Australia, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Hobart, Australia, 10 – 13 November 2019, http://dx.doi.org/10.1111/dar.12991
  • Nguyen QA; Middleton P; Herman D; Li K; Grundy E; Li E; Siefried KJ; Malone V; Kay-Lambkin F; Ezard N. ‘What’s in an app? Incorporating an automated consent procedure to recruit those who use methamphetamine to a harm reduction and early intervention smartphone-based application clinical trial’, in Drug and Alcohol Review, Wiley, Hobart, Australia, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Hobart, Australia, 10 – 13 November 2019, http://dx.doi.org/10.1111/dar.12991
  • Siefried KJ; Nguyen QA; Ezard N; Christmass M; Ali R on behalf of the NCCRED Methamphetamine and Emerging Drugs Clinical Research Network Working Group. ‘A rapid clinical research priority setting study for substance use disorder due to methamphetamine and emerging drugs of concern in Australia’, in Drug and Alcohol Review, Wiley, Hobart, Australia, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Hobart, Australia, 10 – 13 November 2019, http://dx.doi.org/10.1111/dar.12991
  • Sandra S; Demerikol A; Branezac M; Ezard N; Siefried KJ; Acheson LS; Bascombe F; Tremonti C; Haber P; Lintzeris N, 2019, ‘Are we detoxing the right people, in the right setting and in the right way? A rapid review of the literature on withdrawal management’, in Drug and Alcohol Review, Wiley, Hobart, Australia, Vol. 38, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Hobart, Australia, 10 November 2019 – 13 November 2019, http://dx.doi.org/10.1111/dar.12991, ROS ID: 1505725
  • Mitchell S; Peacock A; Ezard N; for the Prompt Response Network Australia. ‘Towards a prompt response network for Australia: rapid health communication about events related to emerging drugs of concern’, The National Centre for Clinical Research on Emerging Drugs (NCCRED) Inaugural Symposium, Hobart, Australia, 10 November 2019
  • Black E; Deacon RM; Mills L; Dunlop A; Ezard N; Bruno R; Shakeshaft A; Farrell M; Holmes J; Cretikos MA; Montebello M; Reid D; Childs S; Siefried KJ; Mammen K; Lintzeris N. ‘Characteristics and treatment outcomes of the drug treatment population in New South Wales: Focus on amphetamine type stimulants’, The National Centre for Clinical Research on Emerging Drugs (NCCRED) Inaugural Symposium, Hobart, Australia, 10 November 2019. http://dx.doi.org/10.1111/dar.12991, ROS ID: 1505722
  • Ezard N; Acheson LS; Siefried KJ; Leicester OM; Rodgers C; Malone V; Clifford B; Bruno R. ‘Substance use sex index (SUSI): A new behaviour change assessment tool’, Lisbon Addictions 2019: The Third European Conference on Addictive Behaviours and Dependencies, Lisbon, Portugal, 23 – 25 October 2019.
  • Mitchell S; Bascombe F; Siefried KJ. ‘Building Australia’s research and treatment capacity for methamphetamine and emerging drugs of concern’, Drug and Alcohol Nurses of Australia (DANA) Annual Conference, Sydney, Australia, 16 August 2019.
  • Ezard N, Dunlop A, Clifford B, Bruno R, Siefried K, Carr A, Lintzeris N. Safety of oral lisdexamfetamine in adults with methamphetamine dependence: a dose-escalating phase-2 study. College on Problems of Drug Dependence, San Antonio, USA, 2019.
  • Ezard N, Siefried K, Peacock A, Developing a national prompt response network for Australia Club Health Conference, Amsterdam, Netherlands, 2019.
  • Siefried K, Peacock A, Ezard N on behalf of the Prompt Response Network, Towards a prompt response network for Australia: coordinated and rapid communication of information about events of concerns related to emerging substances. Poster, New Psychoactive Substances, Maastricht, Netherlands, 2019
  • Hamilton M, Ezard N. Keynote National Centre for Clinical Research on Emerging Drugs of Concern. NADA Conference, Sydney Australia 2018.
  • Bruno R, Ezard N, Dunlop AJ, Clifford B, Carr A, Lintzeris N., 2017, ‘Cognitive effects of escalating doses of oral lisdexamfetamine in methamphetamine dependent adults’, in Drug and Alcohol Review, Wiley, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Melbourne, Australia, 12 – 15 November 2017, https://doi.org/10.1111/dar.12613 ROS ID: 1289892
  • Ezard N, Dunlop AJ, Carr A, McKetin R, Ali R, White J, Bruno R, Dolan K, Clifford B, Lintzeris N, 2016, ‘A randomised, double-blind, placebo-controlled study of Lisdexamfetamine for the treatment of methamphetamine dependence: The LiMA study protocol’, in Drug and Alcohol Review, Wiley presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Sydney, Australia, 30 Oct – 2 November 2016, https://doi.org/10.1111/dar.12484 ROS ID: 899344
  • Van Gordon K, Malone V, Magee F, Clifford B, Ezard N, 2016, ‘Barriers to Stimulant Treatment Access for women who use Methamphetamine in Inner sydney: A qualitative study’ in Drug and Alcohol Review, Wiley, presented at Australasian Professional Society on Alcohol and other Drugs (APSAD) Scientific Conference, Sydney, Australia, 30 Oct – 2 November 2016, https://doi.org/10.1111/dar.12484 ROS ID: 899941