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Psilocybin Therapy for Methamphetamine Use Disorder and HIV

ConditionsMethamphetamine Use DisorderHuman Immunodeficiency Virus (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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Psilocybin 5 mg

    Drug

    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 mg

    Drug

    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 Support

    Behavioral

    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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: High-Dose PsilocybinExperimental treatment 2 interventions
Group B: Low-Dose PsilocybinActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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)
2

Dosing Completion

Proportion of enrolled participants who receive psilocybin dosing.

Time frame
Baseline to Dosing Visit (approximately 10 days)
3

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)
4

Acceptability

Scores on an end-of-treatment acceptability questionnaire.

Time frame
Visit 9, approximately 38 days

Secondary outcomes

1

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nicky Mehtani, MD, MPH

Lead sponsor

University of California, San Francisco

Sponsor institution

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: