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

Citation

Ezard, N and Dunlop, A and Hall, M and Ali, R and McKetin, R and Bruno, R and Phung, N and Carr, A and White, J and Clifford, B and Liu, Z and Shanahan, M and Dolan, K and Baker, AL and Lintzeris, N, LiMA: a study protocol for a randomised, double-blind, placebo controlled trial of lisdexamfetamine for the treatment of methamphetamine dependence, BMJ Open, 8, (7) pp. e020723. ISSN 2044-6055 (2018) [Refereed Article]


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Copyright 2018 The Authors. Licensed under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0) https://creativecommons.org/licenses/by-nc/4.0/

DOI: doi:10.1136/bmjopen-2017-020723

Abstract

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. 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.

Item Details

Item Type:Refereed Article
Keywords:methamphetamine, treatment, lisdexamphetamine
Research Division:Psychology and Cognitive Sciences
Research Group:Other Psychology and Cognitive Sciences
Research Field:Psychology and Cognitive Sciences not elsewhere classified
Objective Division:Health
Objective Group:Public Health (excl. Specific Population Health)
Objective Field:Substance Abuse
UTAS Author:Bruno, R (Associate Professor Raimondo Bruno)
ID Code:132591
Year Published:2018
Funding Support:National Health and Medical Research Council (1109466)
Web of Science® Times Cited:3
Deposited By:Psychology
Deposited On:2019-05-14
Last Modified:2019-06-14
Downloads:6 View Download Statistics

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