[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nicky Mehtani, MD, MPH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100651248","phase-2-psilocybin-therapy-for-methamphetamine-use-disorder-and-hiv-100651248",false,"NCT07756736","Psilocybin Therapy for Methamphetamine Use Disorder and HIV","Psilocybin Recovery Intervention for Stopping Methamphetamine Use","PRISM","Inclusion Criteria:\n\n* Age 25 to 64\n* Diagnosed with HIV at least 3 months ago\n* Moderate-to-severe methamphetamine use disorder\n* Uses methamphetamine regularly and identifies it as their primary drug\n* Has a goal of quitting methamphetamine use\n* Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions\n* Currently living indoors with stable housing anticipated for the duration of the study\n* Has a text-capable cellphone\n* Willing to use highly effective contraception and not donate sperm throughout the study\n* Able to participate in study procedures in English\n\nExclusion Criteria:\n\n* History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric conditions as determined by study assessment\n* Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible)\n* Currently taking certain medications that may interact with psilocybin\n* Recent use of a psychedelic drug\n* Certain significant heart, liver, or kidney conditions\n* Uncontrolled high blood presure (i.e., \\>150\u002F90 mmHg)\n* History of stroke or seizure in the past year\n* Current pregnancy or breastfeeding\n* Current involvement in the criminal legal system that would be expected to interfere with study participation\n* Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month\n\nNote: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.","ALL","25 Years","64 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn whether it is possible to use psilocybin in combination with motivational support therapy to treat moderate-to-severe methamphetamine use disorder (MeUD) in people with HIV who are seeking to stop using methamphetamine. The main questions it aims to answer are:\n\n* Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment?\n* Is psilocybin safe and tolerable among people with HIV and MeUD?\n\nParticipants will:\n\n* Be randomly assigned to receive a single monitored dose of either 25 mg (higher dose) or 5 mg (lower dose) psilocybin\n* Have 3 preparation and 3 integration motivational support therapy visits before and after the psilocybin dosing session.\n* Report their methamphetamine use prior to, during, and up to 3 months following the intervention\n* Optionally receive one additional open-label 25 mg psilocybin session after the 4-week assessment, if eligible",[28,29],"Methamphetamine Use Disorder","Human Immunodeficiency Virus (HIV)",[31,32,33,34,35,36,37,38,39],"methamphetamine use disorder","HIV","methamphetamine","psilocybin","amphetamine-related disorders","stimulant use disorder","people with HIV","psychedelics","psychedelic-assisted therapy","NOT_YET_RECRUITING","2026-08-05",{"date":43,"type":44},"2026-08-11","ACTUAL",{"date":46,"type":22},"2026-11",{"date":48,"type":22},"2029-06",{"name":50,"class":51},"Nicky Mehtani, MD, MPH","OTHER",""]