Psilocybin for Methamphetamine Addiction

SP
NS
Overseen ByNoah Sweat, BS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether psilocybin-assisted treatment can help adults stop using methamphetamine. Participants receive a single oral dose of psilocybin during a supervised session, paired with brief cognitive behavioral therapy, and are followed for up to six months. The study is supported by the HEAL Initiative (https://www.nih.gov/heal).

Who Is on the Research Team?

PS

Peter S Hendricks, PhD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for adults who are struggling with methamphetamine addiction and want to stop using. People with certain medical or psychiatric conditions, or those taking medications that could interact with psilocybin, may not be able to join.

Inclusion Criteria

A friend or family member available for post-session release
DSM-5 moderate or severe Methamphetamine Use Disorder
Severity of Dependence Scale score ≥ 4
See 6 more

Exclusion Criteria

Plan to relocate within 6 months
Pregnancy or breastfeeding, or not using effective contraception
Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preparation

Participants undergo two preparation sessions before psilocybin administration

1-2 weeks

Treatment

Participants receive a single oral dose of psilocybin during an 8-hour supervised session

1 day
1 visit (in-person)

Integration

Participants attend two integration sessions following psilocybin administration

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days (UG3) and 180 days (UH3)

What Are the Treatments Tested in This Trial?

Interventions

  • Psilocybin

Trial Overview

The study tests if a single dose of psilocybin (at one of two possible strengths) combined with brief cognitive behavioral therapy can help people reduce or quit methamphetamine use. Participants are monitored for up to six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Psilocybin, Dose BExperimental Treatment2 Interventions
Group II: Psilocybin, Dose AExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Peter Hendricks

Lead Sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+