Evidence map›Paper›PMID 36190973›Full record

ArticlePloS one2022

Trial protocol of an open label pilot study of lisdexamfetamine for the treatment of acute methamphetamine withdrawal.

Liam S Acheson, Nadine Ezard, Nicholas Lintzeris, Adrian Dunlop, Jonathan Brett, Craig Rodgers, Anthony Gill, Michael Christmass, Rebecca McKetin, Michael Farrell and 2 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.7field-weighted citation impact, top 30% of its field
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

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Review
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

12 authors at 6 institutions in 2 countries.

Liam S AchesonThe National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.ORCID 0000-0002-2343-5504
Nadine EzardAlcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.
Nicholas LintzerisNew South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Sydney, Australia.
Adrian DunlopNew South Wales Drug and Alcohol Clinical Research and Improvement Network (DACRIN), Sydney, Australia.
Jonathan BrettClinical Pharmacology and Toxicology, St Vincent's Hospital Sydney, Sydney, Australia.
Craig RodgersAlcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.
Anthony GillAlcohol and Drug Service, St Vincent's Hospital Sydney, Sydney, Australia.
Michael ChristmassNext Step Drug and Alcohol Services, Perth, Australia.ORCID 0000-0001-9782-1849
Rebecca McKetinThe National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.
Michael FarrellThe National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.
Steve ShoptawDepartment of Family Medicine, The University of California Los Angeles, Los Angeles, California, United States of America.ORCID 0000-0002-3583-0026
Krista J SiefriedThe National Drug and Alcohol Research Centre (NDARC), the University of New South Wales, Sydney, Australia.
UNSW Sydney · AUSt Vincent's Hospital Melbourne · AUCurtin University · AUHunter New England Local Health District · AUThe University of Sydney · AUUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMethamphetamine (MA) use disorder is an important public health concern. MA withdrawal is often the first step in ceasing or reducing use. There are no evidence-based withdrawal treatments, and no medication is approved for the treatment of MA withdrawal. Lisdexamfetamine (LDX) dimesilate, used in the treatment of attention deficit hyperactivity disorder and binge eating disorder has the potential as an agonist therapy to ameliorate withdrawal symptoms, and improve outcomes for patients.

methodsA single arm, open-label pilot study to test the safety and feasibility of LDX for the treatment of MA withdrawal. Participants will be inpatients in a drug and alcohol withdrawal unit, and will receive a tapering dose of LDX over five days: 250mg LDX on Day 1, reducing by 50mg per day to 50mg on Day 5. Optional inpatient Days 6 and 7 will allow for participants to transition to ongoing treatment. Participants will be followed-up on Days 14, 21 and 28. All participants will also receive standard inpatient withdrawal care. The primary outcomes are safety (measured by adverse events, changes in vital signs, changes in suicidality and psychosis) and feasibility (the time taken to enrol the sample, proportion of screen / pre-screen failures). Secondary outcomes are acceptability (treatment satisfaction questionnaire, medication adherence, concomitant medications, qualitative interviews), retention to protocol (proportion retained to primary and secondary endpoints), changes in withdrawal symptoms (Amphetamine Withdrawal Questionnaire) and craving for MA (visual analogue scale), and sleep outcomes (continuous actigraphy and daily sleep diary). DISCUSSION: This is the first study to assess lisdexamfetamine for the treatment of acute MA withdrawal. If safe and feasible results will go to informing the development of multi-centre randomised controlled trials to determine the efficacy of the intervention.

Indexed as

AlcoholismAmphetamine-Related DisordersAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsMethamphetamineSubstance Withdrawal SyndromeDouble-Blind MethodHumansLisdexamfetamine DimesylatePilot ProjectsTreatment OutcomeCentral Nervous System StimulantsLisdexamfetamine DimesylateMethamphetamine

Identifiers

PMID36190973
PMCPMC9529099
OpenAlexW4300690122

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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 OpenQuestion graph.