Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial)
Introduction Methamphetamine 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 sustain...
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BMJ Publishing Group
2025-02-01
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| Online Access: | https://bmjopen.bmj.com/content/15/2/e092504.full |
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| author | Jonathan Brett Celia Morgan Nadine Ezard Brendan Clifford Krista J Siefried Robert May Liam Acheson Kathryn Fletcher Harriet MacDonald Gillinder Bedi Alexandre Guerin Elizabeth Knock Michael Millard Jess Doumany |
| author_facet | Jonathan Brett Celia Morgan Nadine Ezard Brendan Clifford Krista J Siefried Robert May Liam Acheson Kathryn Fletcher Harriet MacDonald Gillinder Bedi Alexandre Guerin Elizabeth Knock Michael Millard Jess Doumany |
| author_sort | Jonathan Brett |
| collection | DOAJ |
| description | Introduction Methamphetamine 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. |
| format | Article |
| id | doaj-art-064ae355e03045fc9d8490d528a650fe |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
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| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-064ae355e03045fc9d8490d528a650fe2025-02-11T10:20:10ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-092504Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial)Jonathan Brett0Celia Morgan1Nadine Ezard2Brendan Clifford3Krista J Siefried4Robert May5Liam Acheson6Kathryn Fletcher7Harriet MacDonald8Gillinder Bedi9Alexandre Guerin10Elizabeth Knock11Michael Millard12Jess Doumany13Clinical Pharmacology and Therapeutics, St Vincent`s Hospital Sydney, Darlinghurst, New South Wales, AustraliaDepartment of Psychology, University of Exeter, Exeter, Devon, UKThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, AustraliaThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, AustraliaThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, AustraliaAlcohol and Drug Service, St Vincent`s Hospital Sydney, Darlinghurst, New South Wales, AustraliaThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, AustraliaThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, AustraliaThe National Centre for Clinical Research on Emerging Drugs; The National Drug and Alcohol Research Centre, University of New South Wales, Sydney, New South Wales, AustraliaCentre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, AustraliaCentre for Youth Mental Health, The University of Melbourne, Melbourne, Victoria, AustraliaAlcohol and Drug Service, St Vincent`s Hospital Sydney, Darlinghurst, New South Wales, AustraliaClinical Research Unit for Anxiety and Depression, St Vincent`s Hospital Sydney, Darlinghurst, New South Wales, AustraliaAustralian Injecting and Illicit Drug Users League, Canberra, Canberra, AustraliaIntroduction Methamphetamine 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.https://bmjopen.bmj.com/content/15/2/e092504.full |
| spellingShingle | Jonathan Brett Celia Morgan Nadine Ezard Brendan Clifford Krista J Siefried Robert May Liam Acheson Kathryn Fletcher Harriet MacDonald Gillinder Bedi Alexandre Guerin Elizabeth Knock Michael Millard Jess Doumany Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial) BMJ Open |
| title | Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial) |
| title_full | Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial) |
| title_fullStr | Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial) |
| title_full_unstemmed | Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial) |
| title_short | Protocol of an open-label safety and feasibility pilot study of ketamine-assisted psychotherapy for methamphetamine use disorder (the KAPPA trial) |
| title_sort | protocol of an open label safety and feasibility pilot study of ketamine assisted psychotherapy for methamphetamine use disorder the kappa trial |
| url | https://bmjopen.bmj.com/content/15/2/e092504.full |
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