This study is not yet accepting patients

Psilocybin Therapy for Methamphetamine Use Disorder and HIV

a study on Methamphetamines HIV/AIDS Immunodeficiency Psilocybin Amphetamines

Summary

Eligibility
for people ages 25-64 (full criteria)
Location
at San Francisco, California
Dates
study started
study ends around
Principal Investigator
by Nicky J. Mehtani, MD, MPH
Headshot of Nicky J. Mehtani
Nicky J. Mehtani

Description

Summary

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

Official Title

Psilocybin Recovery Intervention for Stopping Methamphetamine Use

Keywords

Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV), HIV, methamphetamine, psilocybin, amphetamine-related disorders, stimulant use disorder, people with HIV, psychedelics, psychedelic-assisted therapy, Acquired Immunodeficiency Syndrome, Motivational Interviewing, Psilocybin 5 mg, Psilocybin 25 mg, Motivational Support

Eligibility

You can join if…

Open to people ages 25-64

  • 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

You CAN'T join if...

  • 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.

Location

  • UCSF at Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Nicky J. Mehtani, MD, MPH
    Nicky Mehtani, MD, MPH is an Assistant Professor in the UCSF Division of General Internal Medicine at San Francisco General Hospital. Her research focuses on the use of psychedelic therapies to address substance use disorders and psychological trauma, with an emphasis on expanding access to these emerging treatments for medically and socially complex populations.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Nicky Mehtani, MD, MPH
ID
NCT07756736
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated