Evidence map›Paper›PMID 27905916›Full record

Trial reportBMC psychiatry2016

Study protocol: a dose-escalating, phase-2 study of oral lisdexamfetamine in adults with methamphetamine dependence.

Nadine Ezard, Adrian Dunlop, Brendan Clifford, Raimondo Bruno, Andrew Carr, Alexandra Bissaker, Nicholas Lintzeris

Open access · goldAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.6field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
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

7 authors at 5 institutions in 1 country.

Nadine EzardAlcohol and Drug Service, O'Brien Centre, St Vincent's Hospital, Sydney, Darlinghurst, 2010, NSW, Australia.
Adrian DunlopDrug and Alcohol Clinical Services, Hunter New England Local Health District, Newcastle Community Health Centre, Newcastle, 2302, NSW, Australia.
Brendan CliffordAlcohol and Drug Service, O'Brien Centre, St Vincent's Hospital, Sydney, Darlinghurst, 2010, NSW, Australia. brendan.clifford@svha.org.au.ORCID http://orcid.org/0000-0002-9178-9013
Raimondo BrunoSchool of Medicine, University of Tasmania, Private Bag 30, Hobart, 7001, TAS, Australia.
Andrew CarrCentre for Applied Medical Research, St Vincent's Hospital, 390 Victoria Street, Darlinghurst, 2010, NSW, Australia.
Alexandra BissakerAlcohol and Drug Service, O'Brien Centre, St Vincent's Hospital, Sydney, Darlinghurst, 2010, NSW, Australia.
Nicholas LintzerisSouth East Sydney Local Health District, The Langton Centre, 591 South Dowling St, Surry Hills, 2010, NSW, Australia.
St Vincent's Hospital Sydney · AUHunter New England Local Health District · AUSt Vincent's Hospital Melbourne · AUThe University of Sydney · AUUniversity of Tasmania · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe treatment of methamphetamine dependence is a continuing global health problem. Agonist type pharmacotherapies have been used successfully to treat opioid and nicotine dependence and are being studied for the treatment of methamphetamine dependence. One potential candidate is lisdexamfetamine, a pro-drug for dexamphetamine, which has a longer lasting therapeutic action with a lowered abuse potential. The purpose of this study is to determine the safety of lisdexamfetamine in this population at doses higher than those currently approved for attention deficit hyperactivity disorder or binge eating disorder. METHODS/

designThis is a phase 2 dose escalation study of lisdexamfetamine for the treatment of methamphetamine dependence. Twenty individuals seeking treatment for methamphetamine dependence will be recruited at two Australian drug and alcohol services. All participants will undergo a single-blinded ascending-descending dose regime of 100 to 250 mg lisdexamfetamine, dispensed daily on site, over an 8-week period. Participants will be offered counselling as standard care. For the primary objectives the outcome variables will be adverse events monitoring, drug tolerability and regimen completion. Secondary outcomes will be changes in methamphetamine use, craving, withdrawal, severity of dependence, risk behaviour and other substance use. Medication acceptability, potential for non-prescription use, adherence and changes in neurocognition will also be measured. DISCUSSION: Determining the safety of lisdexamfetamine will enable further research to develop pharmacotherapies for the treatment of methamphetamine dependence.

trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12615000391572 Registered 28

Indexed as

MethamphetamineAdultAmphetamine-Related DisordersAustraliaCentral Nervous System StimulantsCounselingDose-Response Relationship, DrugFemaleHumansLisdexamfetamine DimesylateMaleSingle-Blind MethodTreatment OutcomeCentral Nervous System StimulantsLisdexamfetamine DimesylateMethamphetamineDose-findingLisdexamfetamineMethamphetaminePharmacotherapyStimulant use disorderStudy protocol

Identifiers

PMID27905916
PMCPMC5134059
OpenAlexW2558130365

What OpenQuestion holds

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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 OpenQuestion graph.