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 2016 The Authors. Licensed under Creative Commons Attribution 4.0 International (CC BY 4.0) https://creativecommons.org/licenses/by/4.0/
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 Type:||Contribution to Refereed Journal|
|Keywords:||methamphetamine dependence, study protocol, lisdexamfetamine, pharmacotherapy, dose-finding, stimulant use disorder|
|Research Division:||Medical and Health Sciences|
|Research Group:||Public Health and Health Services|
|Research Field:||Public Health and Health Services not elsewhere classified|
|Objective Group:||Public Health (excl. Specific Population Health)|
|Objective Field:||Substance Abuse|
|UTAS Author:||Bruno, R (Associate Professor Raimondo Bruno)|
|Funding Support:||National Health and Medical Research Council (1109466)|
|Web of Science® Times Cited:||2|
|Downloads:||121 View Download Statistics|
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