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The use of methamphetamine also increases risks for sexually transmitted infections (STIs) by reducing behavioural inhibitions while enhancing sexual libido, disproportionately affecting sexual and gender minorities. The overlap of MeUD with HIV risks and psychological trauma underscores the need for innovative, accessible and culturally responsive therapies. Ketamine-assisted psychotherapy (KAP), which has shown promise for treatment-resistant depression and other substance use disorders, has yet to be explored for MeUD. The Ketamine-Assisted Recovery (KARE) trial seeks to address this gap.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>KARE is an open-label pilot study enrolling N=12\u201324 Medicaid-insured or Medicare-insured adults with moderate-to-severe MeUD and HIV risk factors. Participants will undergo three office-based intramuscular ketamine (0.50\u20130.75\u2009mg\/kg) sessions in combination with seven sessions of motivational enhancement therapy over 5\u2009weeks. Recruitment efforts target community-based organisations, outpatient clinics offering HIV and STI testing\/treatment, and substance use disorder treatment programmes. Feasibility, acceptability and tolerability will be assessed via recruitment and a priori retention benchmarks, surveys and semistructured interviews exploring participants\u2019 perceptions of KAP and ketamine\u2019s misuse potential. Safety will be evaluated through systematic monitoring for adverse events and serial measurement of vital signs during dosing.<\/jats:p>\n                    <jats:p>Secondary outcomes will measure changes in methamphetamine use, craving, withdrawal, HIV risk behaviours and psychological distress, as well as psychological and cognitive flexibility as potential mechanisms of ketamine\u2019s effects, laying the groundwork for future randomised controlled trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>Ethics approval has been obtained from the University of California, San Francisco Institutional Review Board (24-41588) and the Research Advisory Panel of California (202422S). Results will be disseminated through national conferences, peer-reviewed publications and presentations to community-based stakeholders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06538285\">NCT06538285<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-100775","type":"journal-article","created":{"date-parts":[[2025,8,25]],"date-time":"2025-08-25T01:45:31Z","timestamp":1756086331000},"page":"e100775","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Ketamine-Assisted Recovery (KARE): protocol for an open-label pilot trial of ketamine-assisted psychotherapy for publicly insured patients with methamphetamine use disorder and HIV risks"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06538285","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4277-6889","authenticated-orcid":false,"given":"Nicky J.","family":"Mehtani","sequence":"first","affiliation":[{"name":"Medicine, University of California, San Francisco, California, USA"},{"name":"Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brian T.","family":"Anderson","sequence":"additional","affiliation":[{"name":"Psychiatry & Behavioral Sciences, University of California, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Irina","family":"Alexander","sequence":"additional","affiliation":[{"name":"Alchemy Community Therapy Center, Oakland, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter S.","family":"Hendricks","sequence":"additional","affiliation":[{"name":"Psychiatry and Behavioral Neurobiology, University of Alabama, Birmingham, Alabama, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jennifer M.","family":"Mitchell","sequence":"additional","affiliation":[{"name":"Psychiatry & Behavioral Sciences, University of California, San Francisco, California, USA"},{"name":"Neurology, University of California, San Francisco, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Phillip O.","family":"Coffin","sequence":"additional","affiliation":[{"name":"Medicine, University of California, San Francisco, California, USA"},{"name":"Center on Substance Use and Health, San Francisco Department of Public Health, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mallory O.","family":"Johnson","sequence":"additional","affiliation":[{"name":"Medicine, University of California, San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2025,8,24]]},"reference":[{"key":"2025123106475027000_15.8.e100775.1","unstructured":"Centers for Disease Control and Prevention, National Center for Health Statistics . 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