Methamphetamine Use Disorder study: Psilocybin vs Motivational Support
Official title Psilocybin Therapy for Methamphetamine Use Disorder and HIV
ClinicalTrials.gov ID: NCT07756736
What this study is testing
What is Psilocybin 5 mg?
Psilocybin 5 mg is an investigational medicine, taken by mouth, being studied as a potential treatment for methamphetamine use disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 64
You may be able to join if
- 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
You likely can't join if
- History of any primary psychotic disorder (e.g., schizophrenia or schizoaffective disorder), bipolar I disorder, or certain other psychiatric...
- 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)
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 25 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Francisco, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.