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A Dose-Escalating, Phase-2 Study of Oral Lisdexamfetamine

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A Dose-Escalating, Phase-2 Study of Oral Lisdexamfetamine Ezard et al. BMC Psychiatry (2016) 16:428 DOI 10.1186/s12888-016-1141-x STUDY PROTOCOL Open Access Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence Nadine Ezard1,2, Adrian Dunlop3, Brendan Clifford1* , Raimondo Bruno4, Andrew Carr5, Alexandra Bissaker1 and Nicholas Lintzeris6,7 Abstract 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. Trial registration: Australian and New Zealand Clinical Trials Registry ACTRN12615000391572 Registered 28th April 2015. Keywords: Methamphetamine, Study protocol, Lisdexamfetamine, Pharmacotherapy, Dose-finding, Stimulant use disorder Background include psychosis (often requiring hospital admission), Background dependence, injecting-related risks, high-risk sexual Amphetamine type stimulants, including methampheta- practices, psychological disturbances, and acute cardio- mine, present a global public health concern. The second vascular and cerebrovascular events [3]. The current most commonly used illicit drug worldwide, approximately standard care for methamphetamine dependence com- 34 million people aged 15–64 (range 14–56 million) were prises psychosocial interventions, which shows modest estimated to be using amphetamine type stimulants in 2010 rates of induction and retention with many effects lost [1] with 17 million people (range 14–21 million) estimated at follow-up [4, 5]. to have dependence [2]. Problems from stimulant use in Agonist-type pharmacotherapies are candidates to Australia are largely related to methamphetamine, and improve treatment outcomes for methamphetamine de- pendence. By mimicking the pharmacodynamic effects of methamphetamine [6], agonists may ameliorate with- * Correspondence: [email protected] 1Alcohol and Drug Service, O’Brien Centre, St Vincent’s Hospital, Sydney, drawal and cravings, attenuate the positive effects of Darlinghurst 2010, NSW, Australia methamphetamine use, enable use reduction or abstinence Full list of author information is available at the end of the article © The Author(s). 2016 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Ezard et al. BMC Psychiatry (2016) 16:428 Page 2 of 8 and/or increase engagement with treatment [7]. Additional Rationale for study harm reduction may be achieved by replacing illegal drug LDX has the potential to improve treatment outcomes use with a legal, orally administered and regulated alter- for methamphetamine dependence, however there have native. Agonist-type pharmacotherapies have successfully been no published trials addressing this question. promoted use reduction and treatment retention in opioid Doses of 100 to 250 mg LDX may be required to dependence [8] and smoking abstinence for nicotine match the 60 to110mg used in trials of dexampheta- dependence [9]. Emerging evidence suggests that dex- mine for methamphetamine dependence. These doses amphetamine may be effective in reducing cocaine use are higher than the 70 mg LDX currently approved for among heroin-maintained individuals [10] and a statis- attention deficit hyperactivity disorder and binge eat- tical trend in improving sustained cocaine abstinence ing disorder. In order to inform the design of phase 3 has been observed in trials of dexamphetamine, moda- trials on the efficacy of LDX as a treatment for meth- fanil and bupropion [11, 12]. amphetamine dependence, the safety of LDX in this Both immediate and extended release forms of dexam- population at the required therapeutic doses needs to phetamine have been trialled as agonist-type pharmaco- be established. therapies for methamphetamine dependence [13–16]. The four most common side effects noted by partici- The active component dexamphetamine induces neuro- pants in clinical trials of LDX are decreased appetite (27%), transmitter release with a similar pattern to metham- insomnia (27%), dry mouth (26%) diarrhea/nausea (both phetamine. Randomized controlled trials using 60 to 7%) in adults with ADHD [18] and dry mouth (36%), head- 110 mg of dexamphetamine have shown a statistically sig- ache (14%), insomnia (14%) and decreased appetite (12%) nificant decrease in amphetamine withdrawal (g ~ 0.57 to in adults with binge eating disorder [26]. LDX is contrain- 0.62 [13, 14]) and craving (g ~ 0.59 [14]) and an increase dicated in persons with known allergy and with concurrent in treatment retention (g ~ 0.72 [13, 14]). Although there or use within the previous 14 days of monoamine oxidase was a significant decrease in methamphetamine use from inhibitors (MAOIs) [18]. There are also warnings and baseline, the trials appear insufficiently powered to elicit a precautions for serious cardiovascular reactions, blood difference from placebo. pressure and heart increases, psychiatric adverse reac- Methamphetamine dependence research is currently lim- tions and peripheral vasculopathy (including Raynaud’s ited by a low number of published, randomized controlled phenomenon). On this basis, known contraindications, trials with adequate sample size, duration and follow-up pre-existing cardiovascular disease and peripheral vas- [17]. More targeted therapy should also be considered, with culopathy will be exclusion criteria for the trial, and increased stimulant dependence at baseline, longer dosing measurement tools specific to blood pressure, heart intervals, higher doses and longer duration of treatment rate, psychiatric symptoms, weight and insomnia will correlating with better clinical outcomes for psychostimu- be administered (see Table 1). Other adverse effects lant dependence [7]. will be elicited by non-directive questioning at study Lisdexamfetamine dimesylate (LDX), a dexamphetamine visits. pro-drug, has been developed for the treatment of atten- tion deficit hyperactivity disorder and binge eating dis- order [18]. Once ingested, LDX undergoes rate-limited Methods hydrolysis by enzymes within red blood cells to release Design l-lysine and dexamphetamine [19]. The in vivo and rate The study is a phase 2, single group, outpatient study limited conversion of LDX provides longer lasting with a study period of 14 weeks, inclusive of screening therapeutic action with pre-clinical studies showing a and follow up. Screening will occur over 2 weeks slower onset and longer lasting dopamine release in rat (weeks −2and−1), and eligible participants commenced striatum compared to similar agonist formulations, im- on the escalation/de-escalation phase (week 1). Escalation mediate release dexamphetamine and methylphenidate of LDX will occur over 4 weeks, beginning at 100 mg/day, [20, 21]. Pharmacokinetic studies have shown longer time with weekly increases of 50 mg to a maximum 250 mg/ to peak, lower maximal concentration and longer duration day. After 2 weeks at 250 mg/day LDX, the dose of LDX of action compared to immediate release dexamphetamine will be reduced weekly by 50 mg/day, ceasing after 1 week [22]. The pro-drug also benefits from a reduced diversion at 100 mg/day. A follow up study visit will occur in week or abuse liability with the kinetics of dexamphetamine 12, 4 weeks after cessation of study drug. The study aims remaining consistent between intranasal, intravenous or to enrol a sample of twenty participants who are seeking oral administration [23, 24]. In clinical studies LDX has treatment for methamphetamine dependence. A diagram- displayed a lower subjective drug liking by stimulant users matic overview
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