[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651248":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":63,"collaborators":67,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":27,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":102,"whyStopped":27,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"High-Dose Psilocybin","EXPERIMENTAL","Participants receive a single oral dose of 25 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive a second optional open-label 25 mg psilocybin session with additional preparatory and integration support.",[13,14],"Drug: Psilocybin 25 mg","Behavioral: Motivational Support",{"label":16,"type":17,"description":18,"interventionNames":19},"Low-Dose Psilocybin","ACTIVE_COMPARATOR","Participants receive a single oral dose of 5 mg psilocybin (PEX010) during a blinded 8-hour dosing visit, delivered within a manualized motivational support framework of 3 preparatory and 3 integration therapy sessions before and after dosing. After 4 weeks following the dosing session, eligible participants may receive an optional open-label 25 mg psilocybin session with additional preparatory and integration support.",[20,13,14],"Drug: Psilocybin 5 mg",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Psilocybin 5 mg","Single oral 5 mg dose of psilocybin, administered as a capsule under direct observation during a monitored \\~8-hour dosing session. Serves as the low-dose active control during the double-blind randomized phase.",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Psilocybin 25 mg","Single oral 25 mg dose of psilocybin, administered as a capsule under direct clinical observation during a monitored \\~8-hour dosing session. Given as the higher dose during the double-blind randomized phase and as the dose used in the optional open-label session.",[9,16],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"BEHAVIORAL","Motivational Support","Manualized motivational support delivered by trained facilitators, adapted from the NIAAA Project MATCH MET manual. During the double-blind phase, participants attend 3 preparatory talk therapy sessions before dosing and 3 integration talk therapy sessions after dosing; the optional open-label session is accompanied by an additional 1 preparatory and 3 integration talk therapy sessions before and after the second (open-label) dose. Sessions support rapport, intention-setting, psilocybin psychoeducation and safety, and post-session meaning-making.",[9,16],[38],"Motivational Enhancement Therapy (MET)",[40],{"name":41,"affiliation":5,"role":42},"Nicky J. Mehtani, MD, MPH","PRINCIPAL_INVESTIGATOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":27,"email":48},"Eliza Banbury, BA","CONTACT","510-985-3522","prism.trial@ucsf.edu",[50],{"facility":51,"status":27,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":27},"UCSF at Zuckerberg San Francisco General Hospital","San Francisco","California","94110","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-122.41942,37.77493,{"lat":61,"lon":60},{"type":64,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Nicky Mehtani, MD, MPH","Principal Investigator",[68],{"name":69,"class":70},"National Institute on Drug Abuse (NIDA)","NIH","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":83,"type":84},30,"ESTIMATED","INTERVENTIONAL",[87],"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",[90,91],"Methamphetamine Use Disorder","Human Immunodeficiency Virus (HIV)",[93,94,95,96,97,98,99,100,101],"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":105,"type":106},"2026-08-11","ACTUAL",{"date":108,"type":84},"2026-11",{"date":110,"type":84},"2029-06",{"name":65,"class":6},1]