Abstract
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.
Highlights
The treatment of methamphetamine dependence is a continuing global health problem
Emerging evidence suggests that dexamphetamine may be effective in reducing cocaine use among heroin-maintained individuals [10] and a statistical trend in improving sustained cocaine abstinence has been observed in trials of dexamphetamine, modafanil and bupropion [11, 12]
The four most common side effects noted by participants in clinical trials of Lisdexamfetamine dimesylate (LDX) are decreased appetite (27%), insomnia (27%), dry mouth (26%) diarrhea/nausea in adults with ADHD [18] and dry mouth (36%), headache (14%), insomnia (14%) and decreased appetite (12%) in adults with binge eating disorder [26]
Summary
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. Background Amphetamine type stimulants, including methamphetamine, present a global public health concern. The second most commonly used illicit drug worldwide, approximately 34 million people aged 15–64 (range 14–56 million) were estimated to be using amphetamine type stimulants in 2010 [1] with 17 million people (range 14–21 million) estimated to have dependence [2]. Problems from stimulant use in Australia are largely related to methamphetamine, and Agonist-type pharmacotherapies are candidates to improve treatment outcomes for methamphetamine dependence. Agonist-type pharmacotherapies have successfully promoted use reduction and treatment retention in opioid dependence [8] and smoking abstinence for nicotine dependence [9]. Emerging evidence suggests that dexamphetamine may be effective in reducing cocaine use among heroin-maintained individuals [10] and a statistical trend in improving sustained cocaine abstinence has been observed in trials of dexamphetamine, modafanil and bupropion [11, 12]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
