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Introduction Methamphetamine dependence is a growing public health concern. There is currently no pharmacotherapy approved for methamphetamine dependence. Lisdexamfetamine LDX dimesylate, used in the treatment of attention-deficit hyperactivity disorder and binge eating disorder, has potential as an agonist therapy for methamphetamine dependence, and possible benefits of reduced risk of aberrant use due to its novel formulation. Methods and analysis A double-blind randomised controlled trial will be used to evaluate the efficacy of LDX in reducing methamphetamine use. All participants will be given access to four sessions of cognitive—behavioural therapy as treatment as usual and receive a 4-week follow-up appointment. The primary outcomes are efficacy change from baseline in days of methamphetamine use by self-report for the last 28 days at week 13 and urinalyses confirmation of methamphetamine use and safety treatment-related adverse events. Additionally, the study will assess the cost-effectiveness of LDX relative to the placebo control. Contact the corresponding author for the full trial protocol. You will be able to get a quick price and instant permission to reuse the content in many different ways. Strength in methods includes allocation concealment, blinding, compliance measuring, drop-out measuring and analyses of results by intention to treat. The fixed-dose design is a limitation; if efficacious, further dose—response relationship studies may be indicated. The duration of active treatment is limited to 12 weeks; if efficacious, further studies will be needed to explore optimum duration of treatment and a reducing regimen. Methamphetamine is a synthetic stimulant of growing global public health importance and an important contributor to the global burden of disease. There is no approved medication for the treatment of methamphetamine dependence. The current standard treatment for methamphetamine dependence relies on psychosocial interventions, primarily cognitive—behavioural therapy CBT -based approaches. However, CBT approaches require a substantial investment by trained therapists, there is often poor engagement with counselling by methamphetamine users, and cognitive impairment associated with severe methamphetamine dependence may limit CBT effectiveness. Many authors have highlighted the potential role of substitution agonist treatment for methamphetamine dependence. Agonist substitution therapies aim to replace harmful drug use with safer alternatives in terms of dose, route of administration and adverse effects. Long-acting agonists can reduce amphetamine withdrawal, 11 craving 12 and decrease the euphoriant and reinforcing effects of extra illicit stimulant use due to cross-tolerance. Agonist therapies for methamphetamine dependence show promise. Lisdexamfetamine, a pharmacologically inactive prodrug, is absorbed after oral administration and is hydrolysed to inactive l-lysine and active DXA by red blood cells. There have been no published randomised controlled trials of lisdexamfetamine for methamphetamine dependence. The objective of the current trial was to test the efficacy of lisdexamfetamine for reducing methamphetamine use among people with methamphetamine dependence, who had not previously responded to psychosocial treatments. We hypothesise that treatment with oral lisdexamfetamine will result in significantly reduced methamphetamine use at 13 weeks compared with placebo in people who are dependent on methamphetamine. Secondary objectives are to examine the changes in physical and mental health, cognitive and psychosocial functioning and well-being between lisdexamfetamine and placebo groups, as well as differences in retention rates, craving and withdrawal symptoms, and severity of dependence. Other secondary objectives are to examine differences in bloodborne virus transmission risk behaviour, criminality and in use of alcohol and other drugs between groups, as well as the abuse liability profile of lisdexamfetamine and the cost-effectiveness of lisdexamfetamine relative to the placebo control. The sample size calculation is based on data from the existing NSW Stimulant Treatment Program clients 30 who meet the inclusion criteria. To detect a mean difference of 4. This study is being conducted in sites experienced in delivering and evaluating interventions in people who are dependent on methamphetamine. Prior use of methamphetamine will be verified by urinalysis. Participants must be willing and able to comply with study requirements, be able to store study medications securely, and be able to provide written, informed consent. Exclusion criteria are sensitivity or previous adverse reaction to lisdexamfetamine, concurrent use or use within the previous 14 days of medications with possible interaction with lisdexamfetamine. Known contraindications for lisdexamfetamine are also exclusion criteria. Individuals with severe medical disorders, including cardiovascular disease, untreated hypertension and peripheral vascular disease, will be ineligible, as will those with severe psychiatric disorders. Other exclusion criteria are dependent use of alcohol or other drugs, exposure to another investigational drug within the 4 weeks prior to screening, unavailability for follow-up, pregnant or lactating women and receipt of current pharmacotherapy treatment for opioid dependence. Potential participants will be prescreened in person or by telephone by a researcher, and if potentially eligible invited to attend for a formal eligibility assessment by a specialist in addiction medicine. The assessment schedule, including eligibility assessments, is outlined in table 1. Eligible participants will be randomised to receive either the lisdexamfetamine or a placebo medication see figure 1. A computer-generated randomisation schedule has been developed by an independent statistician and uploaded to the study database. Randomisation will be performed by the trial site pharmacist within the study database. The randomisation component of the database has been safe guarded with specific user rights allowing only the trial site pharmacist, the statistician and the chair of the Independent Data and Safety Monitoring Committee IDSMC to access randomisation allocations. Study participants, investigators, clinical and research staff will be blinded to the treatment condition allocated to reduce the risk of bias. Emergency unbinding will be permitted if required for safety of a participant, ongoing safe conduct of the trial or in the case of pregnancy. Trial schema: potential participants will be screened for eligibility. Individuals, who meet the eligibility criteria and provide written informed consent to participate, will be randomised to lisdexamfetamine LDX or a placebo medication. Treatment will be for 15 weeks with a follow visit 4 weeks post-treatment. Trial medications will be obtained, prepacked in child resistant blister packs, stored and transported to participating sites by a contracted good manufacturing practice registered facility in accordance with the Poisons and Therapeutic Goods Act and the Poisons and Therapeutic Goods Regulation The active drug lisdexamfetamine dimesylate and the placebo shall be provided in identical capsules to ensure the study blind. On the fifth day, the participant will be provided with two additional doses self-administer orally once a day. During the maintenance phase, participants will visit the clinic two times per week for a nursing review where vital signs will be recorded, adverse events monitored and medication adherence counselling undertaken. Participants will be required to return study medication packs for pill counts. A urine sample will be provided at each of the two times per week visits, one of which will be randomly selected according to a predetermined randomised schedule and sent for testing at the end of the study for the presence of methamphetamine, and the other stored for future use. Once each week study personnel will collect self-reported methamphetamine use for the previous week. If the participant experiences a grade 2 or 3 adverse event at any time that is considered to be related to the study drug, the study doctor shall consult with the trial chairperson about the option of withholding one dose. If a dose is withheld the participant will be reviewed by the study doctor the following day, or sooner as clinically indicated. If the adverse event is resolved the following day, the dose can be recommenced and the participant will be reviewed the subsequent day. If the adverse event is not resolved or recurs after recommencing, the study doctor will then consult with the trial chairperson with regard to ceasing the medication and withdrawing the participant from the treatment component of the study. During the reduction phase the dose will be tapered so as to minimise any drug discontinuation effects. Lisdexamfetamine will not be available for the management of methamphetamine dependence following completion of the study. However, ongoing treatment will be individualised to the participant and outlined in a treatment plan which will be developed at week 13 by the study doctor. Subjects will have a follow-up visit 4 weeks after cessation of the reduction phase week Participants will be reimbursed with a supermarket voucher that cannot be spent on alcohol or cigarettes at weeks 1, 5, 9, 13 and All participants will be offered counselling representing best practice treatment as usual. In addition to safety concerns including acute psychosis, suicidal or homicidal ideation or pregnancy, participants may be withdrawn from the study if they are absent from study treatment for more than two consecutive weeks. They will also be withdrawn from the study if they become subject to drug testing for legal or occupational reasons due to the risk of unblinding to group allocation. Participants who have discontinued protocol treatment will be offered the opportunity continue to participate in all remaining research interviews and assessments. For those participants who revoke their consent for the entire study, no further data will be collected from the participant. All efficacy analyses will use an intention-to-treat ITT approach. ITT will be defined as all randomised patients who received at least one dose of the prescribed medication. The primary efficacy measure is the change from baseline in days of methamphetamine use self-reported for the last 28 days at week A likelihood-based mixed model of repeated measures MMRM approach will be used for the primary efficacy analysis. The difference between two groups at week 13 will be the primary comparison, and differences at week 5, 9 and 19 will also be examined. Kaplan-Merrier curve, log rank test and Cox proportional hazard model will be applied in the time to event data analysis. All patients enrolled in the study will be evaluated with respect to safety-related outcomes. Safety data will be analysed according to the treatment that the patients actually received. Safety analyses will include summaries of the incidence of all adverse events that are possibly or probably treatment related, that occur during the study treatment period or within 30 days of the last dose of study treatment. Additionally, the study will assess the cost-effectiveness of lisdexamfetamine relative to the placebo control. Costs will include clinical resources, other healthcare, crime, productivity and personal costs. The costs will be summed and combined with the outcome measure, and the incremental cost-effectiveness ratio calculated. All tests of the treatment effect will be conducted at a two-sided alpha level of 0. Interim analyses will be performed when the 50th patient has completed treatment or 6 months after the commencement of recruitment, whichever comes first. An IDSMC will monitor the progress of the study with the aim of safeguarding trial participants by assessing the safety and efficacy of the drug being investigated in the trial. REDCap 38 is a secure, web-based application designed to support data capture for research studies, providing: 1 an intuitive interface for validated data entry; 2 audit trails for tracking data manipulation and export procedures; 3 automated export procedures for seamless data downloads to common statistical packages and 4 procedures for importing data from external sources. If they agree to participate, they will be asked to sign the study-specific consent form. Participants will also be invited to consent for their urine samples to be stored for future research. To ensure anonymity and to limit disclosure, participants will be assigned a unique identifier at the time of randomisation. Results arising from the main study will be published in peer-reviewed journals, and disseminated at international conferences. Results will be reported in such a manner that participants will not be identifiable in any way. All data will be considered the property of the trial chairperson who, in consultation with the trial management committee, will be responsible for presentations and publications arising from this trial. The initial concept of investigating the use of lisdexamfetamine in reducing methamphetamine use in people who are dependent on methamphetamine was proposed by a patient who prefers to be unnamed. No other patients were involved in setting the research question or the outcome measures, nor have they been involved in developing plans for design or implementation of the study. This is the first phase III trial of lisdexamfetamine for methamphetamine dependence. The strength of this study is in its proposed sample size, powered to detect a medium effect size in between group differences in the primary outcome days of methamphetamine use , using a higher dose of agonist medication more than triple used typically for the treatment of attention-deficit hyperactivity disorder. Participants will be closely monitored with two times per week clinic visits and nursing reviews and monthly medical reviews. Two times per week, dispensing will promote retention in the study, and prevent high drop-out rates experienced in other studies. Limitations of the study include the fixed-dose design, active treatment restricted to 12 weeks and two times per week observed dosing. If efficacious further dose—response relationship studies may be indicated to explore optimum duration of treatment and a reducing regimen. If successful the intervention will provide a much needed therapeutic adjunct for people who are dependent on methamphetamine. KD contributed to the design of the protocol. Disclaimer The contents of the published material are solely the responsibility of the individual authors and do not reflect the views of the NHMRC nor the Curran Foundation. Competing interests AC reports grants, personal fees and non-financial support from Gilead Sciences, grants, personal fees and non-financial support from ViiV Healthcare, grants and personal fees from MSD and personal fees from Mayne Healthcare, outside the submitted work. NL reports personal fees from Indivior, personal fees from Mundipharma, grants from Braeburn Pharmaceuticals outside the submitted work. AD reports grants from Braeburn Pharmaceuticals during the conduct of the study. Provenance and peer review Not commissioned; externally peer reviewed. Skip to main content. Log In More Log in via Institution. Log in via OpenAthens. Log in using your username and password For personal accounts OR managers of institutional accounts. Forgot your log in details? Register a new account? Forgot your user name or password? Search for this keyword. Advanced search. Latest content Archive For authors About Browse by collection. Log in via Institution. You are here Home Archive Volume 8, Issue 7 LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence. Email alerts. Article Text. Article menu. LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence. Abstract Introduction Methamphetamine dependence is a growing public health concern. Statistics from Altmetric. Background Methamphetamine is a synthetic stimulant of growing global public health importance and an important contributor to the global burden of disease. Objectives The objective of the current trial was to test the efficacy of lisdexamfetamine for reducing methamphetamine use among people with methamphetamine dependence, who had not previously responded to psychosocial treatments. Sample size The sample size calculation is based on data from the existing NSW Stimulant Treatment Program clients 30 who meet the inclusion criteria. Participants This study is being conducted in sites experienced in delivering and evaluating interventions in people who are dependent on methamphetamine. View this table: View inline View popup. Randomisation Eligible participants will be randomised to receive either the lisdexamfetamine or a placebo medication see figure 1. Figure 1 Trial schema: potential participants will be screened for eligibility. Statistical methods All efficacy analyses will use an intention-to-treat ITT approach. Participants will also be invited to consent for their urine samples to be stored for future research To ensure anonymity and to limit disclosure, participants will be assigned a unique identifier at the time of randomisation. Patient involvement The initial concept of investigating the use of lisdexamfetamine in reducing methamphetamine use in people who are dependent on methamphetamine was proposed by a patient who prefers to be unnamed. Discussion This is the first phase III trial of lisdexamfetamine for methamphetamine dependence. References 1. Estimating the number of regular and dependent methamphetamine users in Australia, Med J Aust ; : The global epidemiology and burden of psychostimulant dependence: findings from the Global Burden of Disease Study Drug Alcohol Depend ; : 36 — Moore T. Working estimates of the social costs per gram and per user for cannabis, cocaine, opiates and amphetamines : National Drug and Alcohol Research Centre , Major physical and psychological harms of methamphetamine use. Drug and Alcohol Review ; 27 : — Dose-related psychotic symptoms in chronic methamphetamine users: evidence from a prospective longitudinal study. JAMA Psychiatry ; 70 : — A systematic review of cognitive and behavioural therapies for methamphetamine dependence. Drug Alcohol Rev ; 27 : — Randomized controlled trial of brief cognitive-behavioural interventions among regular users of amphetamine. Addiction ; 96 : — Predicting in-treatment performance and post-treatment outcomes in methamphetamine users. Addiction ; Suppl 1 : 84 — Agonist-like, replacement pharmacotherapy for stimulant abuse and dependence. Addict Behav ; 29 : — Symptoms and sleep patterns during inpatient treatment of methamphetamine withdrawal: a comparison of mirtazapine and modafinil with treatment as usual. J Subst Abuse Treat ; 35 : — Bupropion reduces methamphetamine-induced subjective effects and cue-induced craving. Neuropsychopharmacology ; 31 : — Evaluation of modafinil effects on cardiovascular, subjective, and reinforcing effects of methamphetamine in methamphetamine-dependent volunteers. Drug Alcohol Depend ; : — Addiction ; : — Efficacy of psychostimulant drugs for amphetamine abuse or dependence. The Cochrane Collaboration , Survey of amphetamine prescribing in England and Wales. Drug Alcohol Rev ; 17 : — Health and psychosocial consequences associated with long-term prescription of dexamphetamine to Amphetamine Misusers in Wolverhampton — Drugs ; 11 : — What do we know about dexamphetamine in the treatment of methamphetamine dependence? Australian Drug Conference; Melbourne, Victoria Pilot randomized controlled study of dexamphetamine substitution for amphetamine dependence. Randomized controlled trial of dexamphetamine maintenance for the treatment of methamphetamine dependence. Jasinski D , Krishnan S , Pharmacokinetics of oral lisdexamfetamine dimesylate LDX; NRP vs d-amphetamine in healthy adults with a history of stimulant abuse. Pennick M. Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine. Neuropsychiatr Dis Treat ; 6 : OpenUrl PubMed. Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in healthy adult volunteers. Curr Med Res Opin ; 24 : 33 — Distribution and elimination of lisdexamfetamine dimesylate: open-label, single-centre, phase i study in healthy adult volunteers. Clinical Drug Investigation ; 28 : — Preclinical pharmacokinetics, pharmacology and toxicology of lisdexamfetamine: A novel d-amphetamine pro-drug. Neuropharmacology ; 87 : 41 — A preclinical evaluation of the discriminative and reinforcing properties of lisdexamfetamine in comparison to d-amfetamine, methylphenidate and modafinil. Neuropharmacology ; 73 : — Jasinski DR , Krishnan S. Abuse liability and safety of oral lisdexamfetamine dimesylate in individuals with a history of stimulant abuse. J Psychopharmacol ; 23 : — Pilot study of the effects of lisdexamfetamine on cocaine use: A randomized, double-blind, placebo-controlled trial. Drug Alcohol Depend ; : 94 — The Journal of Clinical Pharmacology ; 50 : — Safety and pharmacokinetics of lisdexamfetamine dimesylate in adults with clinically stable schizophrenia: a randomized, double-blind, placebo-controlled trial of ascending multiple doses. Journal of clinical psychopharmacology ; 34 : — 9. Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence. BMC Psychiatry ; 16 : Abstract: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence. Drug and Alcohol Review ; 35 : 4 — Brief cognitive behavioural interventions for regular amphetamine users: a step in the right direction. Accounting for dropout bias using mixed-effects models. J Biopharm Stat ; 11 : 9 — Treatment effectiveness score as an outcome measure in clinical trials. NIDA research monograph ; : — Research electronic data capture REDCap —A metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform ; 42 : — Impact of lisdexamfetamine on retention of methamphetamine-dependent patients in a residential facility. Drug Alcohol Depend ; : e The Columbia—Suicide severity rating scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry ; : — The Wender Utah Rating Scale: an aid in the retrospective diagnosis of childhood attention deficit hyperactivity disorder. Sobell LC SM. Psychiatry ; 3 : 36 — 9. Validation of a general measure of treatment satisfaction, the Treatment Satisfaction Questionnaire for Medication TSQM , using a national panel study of chronic disease. Health Qual Life Outcomes ; 2 : The brief psychiatric rating scale. Psychol Rep ; 10 : — OpenUrl CrossRef. The PHQ validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med ; 64 : — Eval Health Prof ; 35 : — Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med ; 2 : — J Am Geriatr Soc ; 53 : — 9. Carter A. Wechsler Test of Adult Reading. Encyclopedia of autism spectrum disorders. New York : Springer New York , : — 5. Rey A. Paris : Presses universitaires de France , Neuropsychological function and delay discounting in methamphetamine-dependent individuals. Psychopharmacology ; : — Neurocognitive effects of methamphetamine: a critical review and meta-analysis. Neuropsychol Rev ; 17 : — Effects of noise letters upon the identification of a target letter in a nonsearch task. Percept Psychophys ; 16 : — 9. Verbal working memory load affects regional brain activation as measured by PET. J Cogn Neurosci ; 9 : — Brief communication derived trail making test indices in a sample of amphetamine abusers: demographic effects. Int J Neurosci ; : — Tombaugh T. Trail making test A and B: normative data stratified by age and education. Archives of Clinical Neuropsychology ; 19 : — Reitan RM. The relation of the trail making test to organic brain damage. J Consult Psychol ; 19 : — 4. Validity of the trail making test as an indicator of organic brain damage. Percept Mot Skills ; 8 : — 6. An evaluation of the evidence that methamphetamine abuse causes cognitive decline in humans. Neuropsychopharmacology ; 38 : — Effects of alcohol and hypnosedative drugs on digit-symbol substitution: comparison of two different computerized tests. J Psychopharmacol ; 11 : — 7. Validity and sensitivity of a pen computer battery of performance tests. J Psychopharmacol ; 15 : — Amphetamine withdrawal: i. A comparison of single-item Visual Analog Scales with a multiitem Likert-type scale for assessment of cocaine craving in persons with bipolar disorder. Addiction ; 90 : — Quality of Life Research ; 20 : — The validity and reproducibility of a work productivity and activity impairment instrument. Pharmacoeconomics ; 4 : — Patient consent Not required. Read the full text or download the PDF:. Log in.

Drugs in Peru: The Laws of Possession

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An Irish man has been arrested in Peru after the seizure of 55kg of cocaine. The year-old was one of three detained by police in the capital city Lima. They had been under surveillance by detectives from Peru's anti-drugs unit, known as Dirandro. Police stopped a rented Nissan car and found suitcases containing the cocaine. The Irish man was arrested along with a British citizen and a Bulgarian. The three men had been under surveillance since entering Peru separately on 21 July, when they were filmed greeting each other at Lima's Jorge Chavez International Airport. It is believed that they rented an apartment in the eastern Lima district of La Molina. Skip to content. US Election. Irish man arrested after Peru cocaine seizure. Getty Images. They believe the drugs were destined for the UK. Surveillance operation. The men appeared in court and were remanded in custody. Republic of Ireland. Drugs trade.

Buying Heroin Lima