Evidence map›Paper›PMID 38907288›Full record

ArticleTrials2024

A phase 3 randomised double-blind placebo-controlled trial of mirtazapine as a pharmacotherapy for methamphetamine use disorder: a study protocol for the Tina Trial.

Rebecca McKetin, Tayla J Degan, Lucy Saunders, Long Nguyen, Gregory Dore, Steven Shoptaw, Michael Farrell, Louisa Degenhardt, Peter J Kelly, Alyna Turner and 27 more

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

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Review
  4. 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

37 authors.

Rebecca McKetinNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia. r.mcketin@unsw.edu.au.ORCID http://orcid.org/0000-0003-2833-4830
Tayla J DeganNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Lucy SaundersNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Long NguyenBurnet Institute, Melbourne, Australia.
Gregory DoreKirby Institute, University of New South Wales, Sydney, Australia.
Steven ShoptawDepartment of Family Medicine, David Geffen School of Medicine, Los Angeles, USA.
Michael FarrellNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Louisa DegenhardtNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Peter J KellySchool of Psychology, Faculty of Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.
Alyna TurnerIMPACT, School of Medicine, Deakin University, Geelong, Australia.
Philip J ClarePrevention Research Collaboration, The University of Sydney, Sydney, Australia.
Olivia M DeanIMPACT, School of Medicine, Deakin University, Geelong, Australia.
Shalini ArunogiriAlfred Psychiatry Research Centre (MAPrc), Central Clinical School, Monash University, Melbourne, Australia.
Samantha Colledge-FrisbyBurnet Institute, Melbourne, Australia.
Juanita KoeijersNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
David Goodman-MezaCenter for HIV Identification, Prevention, and Treatment Services, Los Angeles, USA.
Barbara SinclairIllawarra Drug and Alcohol Service, Illawarra Shoalhaven Local Health District, NSW Health, Wollongong, Australia.
David ReidIllawarra Drug and Alcohol Service, Illawarra Shoalhaven Local Health District, NSW Health, Wollongong, Australia.
Harry HillDrug and Alcohol Services, Barwon Health, Geelong, Australia.
Jeremy HayllarBiala City Community Health Centre, Metro North Health, Brisbane, Australia.
Michael ChristmassNext Step Community Alcohol and Drug Service East Perth, East Perth, Australia.
Frank CordaroIllawarra Drug and Alcohol Service, Illawarra Shoalhaven Local Health District, NSW Health, Wollongong, Australia.
Robert LundinDrug and Alcohol Services, Barwon Health, Geelong, Australia.
Willy LiawDrug and Alcohol Services of South Australia, Adelaide, Australia.
Danica LiuDrug and Alcohol Services of South Australia, Adelaide, Australia.
Ellie HolyoakAlcohol, Tobacco & Other Drug Services, Townsville, Australia.
Brian Tid-Fung WuAlcohol, Tobacco & Other Drug Services, Townsville, Australia.
Joel KeyganNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Ava KontogiannisSchool of Psychology, Faculty of Arts, Social Sciences and Humanities, University of Wollongong, Wollongong, Australia.
Lily PalmerNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Caity MorrisonIMPACT, School of Medicine, Deakin University, Geelong, Australia.
Anna WrobelIMPACT, School of Medicine, Deakin University, Geelong, Australia.
Bec HylandNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Marianne ByrneKirby Institute, University of New South Wales, Sydney, Australia.
Samantha RussellIMPACT, School of Medicine, Deakin University, Geelong, Australia.
Emma ZahraNational Drug and Alcohol Research Centre, University of New South Wales, Sydney, Australia.
Michael BerkIMPACT, School of Medicine, Deakin University, Geelong, Australia.

Funding

UCLA Rapid, Relevant, Rigorous Implementation Science HubP30MH058107 · NIMH · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI RAPHAEL J LANDOVITZ · 1997 to 2026
$53.5M
Medical Research Future Fund (AU) 2007155NIMH NIH HHS P30 MH058107
6 · The paper itself

Abstract

backgroundThere are no approved pharmacotherapies for methamphetamine use disorder. Two preliminary phase 2 randomised controlled trials have found mirtazapine, a tetracyclic antidepressant, to be effective in reducing methamphetamine use. The proposed Tina Trial is the first phase 3 placebo-controlled randomised trial to examine the effectiveness and safety of mirtazapine as an outpatient pharmacotherapy for methamphetamine use disorder.

methodsThis is a multi-site phase 3 randomised, double-blind, placebo-controlled parallel trial. Participants are randomly allocated (1:1) to receive either mirtazapine (30 mg/day for 12 weeks) or matched placebo, delivered as a take-home medication. The target population is 340 people aged 18-65 years who have moderate to severe methamphetamine use disorder. The trial is being conducted through outpatient alcohol and other drug treatment clinics in Australia. The primary outcome is measured as self-reported days of methamphetamine use in the past 4 weeks at week 12. Secondary outcomes are methamphetamine-negative oral fluid samples, depressive symptoms, sleep quality, HIV risk behaviour and quality of life. Other outcomes include safety (adverse events), tolerability, and health service use. Medication adherence is being monitored using MEMS® Smart Caps fitted to medication bottles. DISCUSSION: This trial will provide information on the safety and effectiveness of mirtazapine as a pharmacotherapy for methamphetamine use disorder when delivered as an outpatient medication in routine clinical practice. If found to be safe and effective, this trial will support an application for methamphetamine use disorder to be included as a therapeutic indication for the prescription of mirtazapine.

trial registrationAustralian and New Zealand Clinical Trials Registry ACTRN12622000235707. Registered on February 9, 2022.

Indexed as

Amphetamine-Related DisordersClinical Trials, Phase III as TopicMethamphetamineMirtazapineRandomized Controlled Trials as TopicAdolescentAdultAgedAntidepressive Agents, TricyclicAustraliaDouble-Blind MethodFemaleHumansMaleMedication AdherenceMiddle AgedAntidepressive Agents, TricyclicMethamphetamineMirtazapineAddictionClinical trialDepressionMethamphetamineMirtazapinePharmacotherapyPsychiatrySleepSubstance use disordersTreatment

Identifiers

PMID38907288
PMCPMC11193254

What OpenQuestion holds

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Registered trials

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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.