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Psilocybin Therapy for Methamphetamine Use Disorder and HIV

Not Yet RecruitingPhase 2

Sponsor: Nicky Mehtani, MD, MPH

Conditions: Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)

Interventions: Psilocybin 5 mg, Psilocybin 25 mg, Motivational Support

Countries: United States

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 overview

Sex: ALL

Age: 25 Years to 64 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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
* Has a goal of quitting methamphetamine use
* Able and willing to abstain from methamphetamine and other non-prescribed drugs for at least 24 hours prior to and throughout psilocybin dosing sessions
* Currently living indoors with stable housing anticipated for the duration of the study
* Has a text-capable cellphone
* Willing to use highly effective contraception and not donate sperm throughout the study
* Able to participate in study procedures in English

Exclusion Criteria:

* 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
* Certain significant heart, liver, or kidney conditions
* Uncontrolled high blood presure (i.e., \>150/90 mmHg)
* History of stroke or seizure in the past year
* Current pregnancy or breastfeeding
* Current involvement in the criminal legal system that would be expected to interfere with study participation
* Current or planned enrollment in a contingency management program or another investigational substance use treatment trial within the past month

Note: Additional eligibility criteria apply. Certain criteria and thresholds are not listed here to preserve the scientific integrity of the study.

Locations (1)

San Francisco, California, United States