Psilocybin Therapy for Methamphetamine Use Disorder and HIV
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age25-64
SponsorNicky Mehtani, MD, MPH
About this trial
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:
* Do people with HIV and MeUD find psilocybin with motivational support therapy feasible and acceptable as a potential treatment? * Is psilocybin safe and tolerable among people with HIV and MeUD?
Participants will:
* Be randomly assigned to receive a single monitored dose of either 25 mg (higher dose) or 5 mg (lower dose) psilocybin * Have 3 preparation and 3 integration motivational support therapy visits before and after the psilocybin dosing session. * Report their methamphetamine use prior to, during, and up to 3 months following the intervention * Optionally receive one additional open-label 25 mg psilocybin session after the 4-week assessment, if eligible
Eligibility criteria
Qualifiers
Age 25 to 64
Diagnosed with HIV at least 3 months ago
Moderate-to-severe methamphetamine use disorder
Uses methamphetamine regularly and identifies it as their primary drug
Disqualifiers
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
Current moderate-to-severe opioid, alcohol, or sedative use disorder (Note: people on stable doses of buprenorphine or methadone may be eligible)
Currently taking certain medications that may interact with psilocybin
Recent use of a psychedelic drug
Trial design
Treatments tested in this trial
- Psilocybin 5 mg
- Psilocybin 25 mg
- Motivational Support
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
Nicky Mehtani, MD, MPH
Lead sponsor
University of California, San Francisco
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov