Evidence map›Paper›PMID 39929500›Full record

ArticleBMJ open2025

Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychothera

Kathryn Fletcher, Nadine Ezard, Krista J Siefried, Harriet MacDonald, Liam Acheson, Gillinder Bedi, Alexandre Guerin, Elizabeth Knock, Michael Millard, Robert May and 4 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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

14 authors.

Kathryn FletcherThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia k.fletcher@unsw.edu.au.ORCID http://orcid.org/0000-0002-8423-8651
Nadine EzardThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-7495-8305
Krista J SiefriedThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-6534-3325
Harriet MacDonaldThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.
Liam AchesonThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.
Gillinder BediCentre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.
Alexandre GuerinCentre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0003-3833-3620
Elizabeth KnockAlcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Michael MillardClinical Research Unit for Anxiety and Depression, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Robert MayAlcohol and Drug Service, St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia.
Jonathan BrettSt Vincent's Clinical School; School of Population Health, University of New South Wales, Sydney, New South Wales, Australia.
Jess DoumanyAustralian Injecting and Illicit Drug Users League, Canberra, Canberra, Australia.
Celia MorganDepartment of Psychology, University of Exeter, Exeter, Devon, UK.
Brendan CliffordThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-9178-9013

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionMethamphetamine use disorder is a significant public health concern. No pharmacological treatment options currently exist for methamphetamine use disorder, and psychotherapy is only moderately effective. Preliminary evidence suggests that ketamine-assisted psychotherapy produces sustained improvements in substance use and mental health symptomatology. In addition to direct antidepressant properties, ketamine is hypothesised to increase synaptogenesis and facilitate neuroplasticity, in turn prolonging and enhancing the effects of psychotherapy. Given the withdrawal-associated dysphoria and neurocognitive impairments characterising methamphetamine use disorder, ketamine-assisted psychotherapy may improve the efficacy of psychotherapy alone by addressing these features and facilitating therapeutic engagement. This pilot study aims to investigate the safety and feasibility (time taken to recruit sample, proportion of ineligible participants at pre-screening and screening, number of participants who complete four sessions of psychotherapy, retention rate over full duration of study, acceptability of the intervention) of subanaesthetic ketamine in combination with psychotherapy (cognitive behavioural therapy) for adults with methamphetamine use disorder. Changes in methamphetamine use, cravings and withdrawal, quality of life, and treatment satisfaction will also be explored. METHODS AND ANALYSIS: This is an open-label, single-arm clinical trial. 20 adults meeting DSM-5-TR criteria for methamphetamine use disorder who are seeking to reduce or cease methamphetamine use will be enrolled in the study through a single-site specialist outpatient stimulant treatment service in inner Sydney (St Vincent's Hospital, Sydney). A 4-week course with three subcutaneous ketamine doses (0.75 mg/kg to 0.9 mg/kg, titrated according to tolerability) at weekly intervals and four sessions of cognitive behavioural therapy (one at treatment initiation and three within 24-48 hours following each ketamine administration session) will be delivered. Safety and feasibility will be assessed over an 8-week period. Secondary outcomes (changes in methamphetamine use, cravings, withdrawal, quality of life and treatment satisfaction) will be assessed over a 24-week period. ETHICS AND DISSEMINATION: This study has been approved by the St Vincent's Hospital Human Research Ethics Committee, reference 2023/ETH00530. Study findings will be disseminated through articles in scientific, peer-reviewed journals, and at national and international conferences. TRIAL REGISTRATION NUMBER: ANZCTR: ACTRN12624000895583. PROTOCOL VERSION: The trial protocol (Version 4.0) was approved on 24 June 2024.

Indexed as

Amphetamine-Related DisordersCognitive Behavioral TherapyKetamineMethamphetaminePsychotherapyAdultCombined Modality TherapyFeasibility StudiesFemaleHumansMaleMiddle AgedPilot ProjectsQuality of LifeTreatment OutcomeKetamineMethamphetamineDrug TherapyFeasibility StudiesPsychosocial InterventionSafetySubstance misuse

Identifiers

PMID39929500
PMCPMC11815421

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.