Randomised double-blind placebo-controlled study of lisdexamfetamine for the treatment of methamphetamine dependence

June 2016

NDRI: Associate Professor Rebecca McKetin

NDARC: Professor Kate Dolan, Professor Michael Farrell (Associate Investigator)

Other investigators: 

Lead investigator: Associate Professor Nadine Ezard, St Vincents & Mater Health Sydney
Associate Professor Nicholas Lintzeris, The University of Sydney
Associate Professor Robert Ali, The University of Adelaide
Associate Professor Adrian Dunlop, Hunter New England Local Health District
Professor Jason White, University of South Australia
Associate Professor Raimondo Bruno, University of Tasmania
Professor Andrew Carr, St Vincent's Centre for Applied Medical Research, Darlinghurst NSW
Associate Investigators: Professor Andrew Dawson, The University of Sydney
Dr Anthony Gill, St Vincent's Drug and Alcohol Service and Central Coast Drug and Alcohol Service
Dr Craig Rodgers, East Sydney Doctors
Associate Professor James Ward, South Australian Health and Medical Research Institute in Adelaide
Dr Mark Montebello, South Eastern Sydney Local Health District Drug and Alcohol Service

Project description: 

This new project aims to examine the safety and efficacy of lisdexamfetamine in the treatment of adults with severe methamphetamine (MA) dependence.

The study is the first controlled trial of maintenance lisdexamfetamine for the treatment of severe methamphetamine dependence, with major clinical and public health implications.

Background: Australia has one of the highest rates of MA use in the world, with evidence of increasing harms such as emergency department presentations and hospital admissions. Existing treatments for MA users rely on psychosocial treatments, however these are of only modest effectiveness, particularly in heavy users of MA. The need to develop safe and effective medications is well recognised, and research to date suggests substitution agonist therapies (as for nicotine and opioid dependence) are most promising for those with severe addiction.

Lisdexamfetamine is a prodrug of dexamphetamine (converted to dexamphetamine in the body after oral dosing) with lower abuse potential (misuse and diversion) than other stimulants. It is an exciting novel medication for treating this patient group, building upon favourable findings of previous pilot studies of dexamphetamine substitution treatment.

Study design: A 4 year multisite (Sydney, Newcastle, Adelaide) double blind placebo controlled randomised controlled trial to be conducted in Australia's only specialist stimulant clinics. Eligible consenting adults (severe MA dependent users who have not previously responded to conventional treatment) will be randomised to 14 weeks of lisdexamfetamine or placebo in addition to counselling and case management. Participants will be followed up 8 weeks after the medication phase. Primary outcome is illicit MA use during the medication phase (self-report and objective urine drug screens). Secondary outcomes include adverse events, abuse liability, physical and mental health, other substance use, cognitive performance, psychosocial functioning, treatment retention and satisfaction.