LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence

Abstract

IntroductionMethamphetamine 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 analysisA double-blind randomised controlled trial will be used to evaluate the efficacy of LDX in reducing methamphetamine use. The target sample is 180 participants with methamphetamine dependence of ≥2 years, using ≥14 days out of the previous 28, who have previously attempted but not responded to treatment for methamphetamine use. Participants will be randomly assigned to receive either a 15-week intervention consisting of induction (1 week of 150 mg LDX or placebo), maintenance (12 weeks of 250 mg LDX or placebo) and reduction (1 week of 150 mg LDX or placebo and 1 week of 50 mg LDX or placebo). 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). Secondary outcomes are total number of days of self-report methamphetamine use over the 12-week active treatment, longest period of abstinence during treatment period, percentage of achieving ≥21 days abstinence, craving, withdrawal, dependence, retention, bloodborne virus transmission risk behaviour, criminal behaviour, as well measures of abuse liability, physical and mental health, other substance use, cognitive performance, psychosocial functioning, treatment retention and satisfaction. Additionally, the study will assess the cost-effectiveness of LDX relative to the placebo control.Ethics and disseminationThe study has been approved by the Human Research Ethics Committee of St. Vincent’s Hospital, Sydney, Australia (HREC/16/SVH/222). Contact the corresponding author for the full trial protocol.Trial registration numberACTRN12617000657325; Pre-results.

Prevalence Rates of Personality Disorder and Its Association With Methamphetamine Dependence in Compulsory Treatment Facilities in China

“…Our study showed that the onset age of MA use was about 23 years old and their average age was 33 years old. For pharmacotherapy, lisdexamfetamine (LiMA) was recommended for the potential MA dependence treatment (64). Except for the above, Repetitive transcranial magnetic stimulation (rTMS) was also a potential treatment for the MA dependence.…”

Pharmacological Treatment of Methamphetamine/Amphetamine Dependence: A Systematic Review

“…Other work in this area is ongoing. One study [68] is currently examining 12 weeks of lisdexamfetamine (a pro-drug of dexamphetamine) versus placebo in a double-blind, RCT of MA-dependent (for at least 2 years) adults with baseline use of at least 14 of the prior 28 days.…”

Safety and tolerability of oral lisdexamfetamine in adults with methamphetamine dependence: a phase-2 dose-escalation study

“…Our group is currently conducting a multicentre, randomised, controlled trial to assess efficacy (ACTRN12617000657325). 52 …”

“…Our group is currently conducting a multicentre, randomised, controlled trial to assess efficacy (ACTRN12617000657325). 52 For people with MA dependence, this study is the first to demonstrate the safety, tolerability and acceptability of higher doses of LDX than used for ADHD. Findings suggest the feasibility of larger scale studies to determine the efficacy of LDX for this indication.…”