Evidence map›Paper›PMID 41309470›Full record

ArticleBMJ open2025

Study protocol for a randomised controlled trial to determine the efficacy of lisdexamfetamine for the treatment of acute methamphetamine withdrawal in inpatient settings.

Liam S Acheson, Krista J Siefried, Nicholas Lintzeris, Adrian J Dunlop, Paul S Haber, Shalini Arunogiri, Michael Christmass, Michael Doyle, Mark Donoghoe, Jack Nagle and 9 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors.

Liam S AchesonNational Centre for Clinical Research on Emerging Drugs, University of New South Wales, Sydney, New South Wales, Australia liam.acheson@svha.org.au.ORCID http://orcid.org/0000-0002-2343-5504
Krista J SiefriedAlcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.ORCID http://orcid.org/0000-0002-6534-3325
Nicholas LintzerisDrug and Alcohol Clinical Research and Improvement Network, NSW Health, St Leonards, New South Wales, Australia.
Adrian J DunlopDrug and Alcohol Clinical Research and Improvement Network, NSW Health, St Leonards, New South Wales, Australia.
Paul S HaberDrug and Alcohol Clinical Research and Improvement Network, NSW Health, St Leonards, New South Wales, Australia.
Shalini ArunogiriMonash Addiction Research Centre, Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Michael ChristmassNext Step Drug and Alcohol Services, Perth, New South Wales, Australia.
Michael DoyleCentre for Research Excellence in Aboriginal Health and Alcohol, Discipline of Medicine, Central Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.
Mark DonoghoeClinical Research Unit, UNSW Medicine & Health, Sydney, New South Wales, Australia.
Jack NagleReal Drug Talk, Melbourne, Victoria, Australia.
Brendan CliffordAlcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.ORCID http://orcid.org/0000-0002-9178-9013
Rebecca McKetinNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.
Dan I LubmanMonash Addiction Research Centre, Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.
Jonathan BrettSt. Vincent's Clinical School, University of New South Wales, Sydney, New South Wales, Australia.
Nathan TaylorPolicy, Ethics, and Research, Aboriginal Health & Medical Research Council, Sydney, New South Wales, Australia.
Andrew CarrApplied Medical Research, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Frances R LevinDepartment of Psychiatry, Columbia University Irving Medical Center, New York State, New York, USA.
Steven ShoptawDepartment of Family Medicine, University of California Los Angeles, Los Angeles, California, USA.
Nadine EzardNational Centre for Clinical Research on Emerging Drugs, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-7495-8305

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionHarms due to methamphetamine use disorder (MAUD) are rising globally. Untreated withdrawal symptoms perpetuate the cycle of dependence and are a barrier to treatment. There is no pharmacotherapy approved for methamphetamine withdrawal. Lisdexamfetamine (LDX) dimesylate has potential as an agonist therapy to ameliorate symptom severity during acute methamphetamine withdrawal and increase duration of initial abstinence and retention in treatment. METHODS AND ANALYSIS: We will conduct a double-blind, randomised, controlled trial to evaluate the efficacy of LDX in reducing symptom severity during acute methamphetamine (MA) withdrawal. One hundred eighty-four adults with moderate to severe MAUD presenting to a health service requesting MA withdrawal treatment who report use of MA within the last 72 hours will be recruited. Participants will be randomised 1:1 to receive a tapering dose of lisdexamfetamine (250 mg on day 1, reducing by 50 mg per day to 50 mg on day 5, followed by 2 days of placebo washout on days 6 and 7), or placebo for 7 days. The study will be conducted over 7 days in an inpatient unit, and all participants will also receive standard inpatient withdrawal care. Participants will be followed up in the community to day 84. The primary outcome is efficacy, defined as the between-group difference in average withdrawal severity measured over the 7-day admission by the Amphetamine Withdrawal Questionnaire. Secondary outcomes are retention in treatment, treatment satisfaction, sleep and concomitant medication use (symptomatic medications and medications for other indications to day 7); safety, craving for MA, post-treatment withdrawal symptoms, depression, anxiety and stress, insomnia and cost effectiveness (to day 28) and MA use, mental, physical and social health and post-withdrawal treatment utilisation (to day 84). A First Nations qualitative substudy will assess the experiences of Aboriginal and Torres Strait Islander participants, ensuring the treatment meets the needs of First Nations people. ETHICS AND DISSEMINATION: This protocol was first approved by the St Vincent's Hospital Human Research Ethics Committee on 15/05/2024 (2024/ETH00788). All participants will be provided with a participant information sheet and consent form, be fully informed about the study and given ample time to consider participation. Results will be published in peer-reviewed journals and presented at national and international conferences. Findings will be presented such that individual participants will not be identifiable. TRIAL REGISTRATION NUMBER: ACTRN12624001061527.

Indexed as

Amphetamine-Related DisordersLisdexamfetamine DimesylateMethamphetamineSubstance Withdrawal SyndromeAdultCentral Nervous System StimulantsDouble-Blind MethodFemaleHumansInpatientsMaleRandomized Controlled Trials as TopicTreatment OutcomeCentral Nervous System StimulantsLisdexamfetamine DimesylateMethamphetamineClinical TrialHospitalsSubstance misuseTreatment Outcome

Identifiers

PMID41309470
PMCPMC12684119

What Socratic holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.