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

BMC Psychiatry

Study Protocol

Alexandra Bissaker¹  Brendan Clifford¹  Nadine Ezard²  Andrew Carr³  Adrian Dunlop⁴  Raimondo Bruno⁵  Nicholas Lintzeris⁶ 

[1] Alcohol and Drug Service, O’Brien Centre, St Vincent’s Hospital, 2010, Sydney, Darlinghurst, NSW, Australia;Alcohol and Drug Service, O’Brien Centre, St Vincent’s Hospital, 2010, Sydney, Darlinghurst, NSW, Australia;St Vincent’s Hospital Clinical School, Faculty of Medicine, UNSW, Sydney, Australia;Centre for Applied Medical Research, St Vincent’s Hospital, 390 Victoria Street, 2010, Darlinghurst, NSW, Australia;Drug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle Community Health Centre, 2302, Newcastle, NSW, Australia;School of Medicine, University of Tasmania, Private Bag 30, 7001, Hobart, TAS, Australia;South East Sydney Local Health District, The Langton Centre, 591 South Dowling St, 2010, Surry Hills, NSW, Australia;Discipline of Addiction Medicine and Lambert initiative in Cannabinoid Therapeutics, University of Sydney, 2006, Sydney, NSW, Australia;

关键词: Methamphetamine;    Study protocol;    Lisdexamfetamine;    Pharmacotherapy;    Dose-finding;    Stimulant use disorder;   

DOI  :  10.1186/s12888-016-1141-x

 received in 2016-03-08, accepted in 2016-11-25,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundThe 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/designThis 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.DiscussionDetermining the safety of lisdexamfetamine will enable further research to develop pharmacotherapies for the treatment of methamphetamine dependence.Trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12615000391572 Registered 28th April 2015.

【 授权许可】

CC BY   
© The Author(s). 2016