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Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence


Ezard, N and Dunlop, A and Clifford, B and Bruno, R and Carr, A and Bissaker, A and Lintzeris, N, Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence, BMC Psychiatry, 16 Article 428. ISSN 1471-244X (2016) [Contribution to Refereed Journal]


Copyright Statement

Copyright 2016 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0)

DOI: doi:10.1186/s12888-016-1141-x


Background: The treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder.

Methods/design: This is a phase 2 dose escalation study of lisdexamfetamine for the treatment of methamphetamine dependence. Twenty individuals seeking treatment for methamphetamine dependence will be recruited at two Australian drug and alcohol services. All participants will undergo a single-blinded ascending-descending dose regime of 100 to 250 mg lisdexamfetamine, dispensed daily on site, over an 8-week period. Participants will be offered counselling as standard care. For the primary objectives the outcome variables will be adverse events monitoring, drug tolerability and regimen completion. Secondary outcomes will be changes in methamphetamine use, craving, withdrawal, severity of dependence, risk behaviour and other substance use. Medication acceptability, potential for non-prescription use, adherence and changes in neurocognition will also be measured.

Discussion: Determining the safety of lisdexamfetamine will enable further research to develop pharmacotherapies for the treatment of methamphetamine dependence.

Item Details

Item Type:Contribution to Refereed Journal
Keywords:methamphetamine dependence, study protocol, lisdexamfetamine, pharmacotherapy, dose-finding, stimulant use disorder
Research Division:Health Sciences
Research Group:Health services and systems
Research Field:Health services and systems not elsewhere classified
Objective Division:Health
Objective Group:Public health (excl. specific population health)
Objective Field:Public health (excl. specific population health) not elsewhere classified
UTAS Author:Bruno, R (Associate Professor Raimondo Bruno)
ID Code:114572
Year Published:2016
Funding Support:National Health and Medical Research Council (1109466)
Web of Science® Times Cited:5
Deposited By:Psychology
Deposited On:2017-02-19
Last Modified:2018-04-20
Downloads:163 View Download Statistics

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