Psilocybin Therapy for Methamphetamine Use Disorder and HIV

Phase 2Not Yet RecruitingNCT07756736

Nicky Mehtani, MD, MPH30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Methamphetamine Use Disorder Human Immunodeficiency Virus (HIV)

Psilocybin 5 mgDRUG

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.

Psilocybin 25 mgDRUG

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.

Motivational SupportBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 25 YearsMax age: 64 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Recruitment Efficiency

Proportion of participants who undergo in-person screening who are fully enrolled in the study and initiate treatment.

Time frame: Screening to Baseline (approximately 35 days)

Dosing Completion

Proportion of enrolled participants who receive psilocybin dosing.

Time frame: Baseline to Dosing Visit (approximately 10 days)

Retention

Proportion of participants receiving psilocybin who complete the end-of-double-blind-period study visit.

Time frame: Dosing Visit to Visit 9 (approximately 28 days)

Acceptability

Scores on an end-of-treatment acceptability questionnaire.

Time frame: Visit 9, approximately 38 days

Adverse Events

Number of participants who experience treatment-emergent adverse events between initial psilocybin dosing and the end-of-double-blind-period visit.

Time frame: Dosing Visit to Visit 9 (approximately 28 days)

Secondary Outcomes

Methamphetamine Use (TLFB)

Change from baseline in self-reported past-month days of methamphetamine use, assessed by Timeline Followback (TLFB), at Day 28 post-dose.

Time frame: Baseline to Visit 9 (approximately 38 days)