Psilocybin for Methamphetamine Use Disorder

NCT07774702 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: IRB-300017113IND 1210001UG3DA067126
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Methamphetamine Use Disorder

Keywords

psilocybin; methamphetamine; HEAL Initiative; psychedelic-assisted therapy; substance use disorder

Outcome Measures

Primary Outcomes (1)

• Abstinent Days

  Percentage of days abstinent from methamphetamine (Timeline Followback, urine-confirmed); possible range is 0% to 100%, with higher scores reflecting more abstinence.

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

Secondary Outcomes (11)

• Complete Abstinence

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

• Methamphetamine Use Disorder in Remission

  30/90-day (UG3), 30/90/180-day (UH3)

• Health-related Quality of Life

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

• Self-perceived Quality of Life

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

• Craving

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

Other Outcomes (2)

• Meaning in Life

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

• Psychosocial-Spiritual Well-Being

  Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3).

Study Arms (2)

Psilocybin, Dose A

EXPERIMENTAL

Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).

Drug: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).; Behavioral: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).

Psilocybin, Dose B

EXPERIMENTAL

Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).

Drug: Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).; Behavioral: Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).

Interventions

Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions). BEHAVIORAL

Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)

Psilocybin, Dose A; Psilocybin, Dose B

Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct). DRUG

The specific doses (in mg) are intentionally omitted from this registration during the conduct of the trial to preserve masking and reduce expectancy effects. The doses will be disclosed when results are reported after primary completion, by which point participants have been debriefed.

Psilocybin, Dose A; Psilocybin, Dose B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• DSM-5 moderate or severe Methamphetamine Use Disorder
• Severity of Dependence Scale score ≥ 4
• Methamphetamine use on more than 7 of the past 30 days and more than one positive urine test before randomization
• A goal of complete abstinence on the Thoughts About Abstinence questionnaire
• Able to read, write, and speak English
• A friend or family member available for post-session release
• Good general health by history and physical
• Confirmed pre-dose abstinence of at least 24 hours (clinically assessed)

You may not qualify if:

• Pregnancy or breastfeeding, or not using effective contraception
• Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder
• Current hypertension (\>140/90 at rest)
• Regular use of centrally acting serotonergic medications or MAO inhibitors (washout/re-screen permitted)
• Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such
• Current suicidal or homicidal ideation
• Plan to relocate within 6 months
• Psychedelic use in the past 3 years, more than 3 lifetime psychedelic occasions, more than 3 lifetime ketamine or MDMA occasions, or any prior 5-MeO-DMT or ibogaine use

Sponsors & Collaborators

• Peter Hendricks: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Psilocybin; Floors and Floorcoverings

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines; Facility Design and Construction; Architecture; Technology, Industry, and Agriculture

Study Officials

• Peter S Hendricks, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seher Premani, MPH

CONTACT

205-975-7721; spremani@uab.edu

Noah Sweat, BS

CONTACT

205-996-0212; nsweat@uabmc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: statistician(s)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: University Professor and Heersink Endowed Chair

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): February 1, 2027
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): February 1, 2032
• Last Updated: September 21, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: De-identified individual participant data and the supporting documents will become available no later than publication of the primary outcome results or the end of the funding period, whichever comes first, and will remain available indefinitely thereafter through the repository.
• Access Criteria: Data will be deposited in an NIH-designated repository accessible through the HEAL Data Ecosystem. Qualified researchers may request the de-identified dataset, data dictionary, and supporting documents through the repository's data-access process. Because these are substance use disorder data, access may be controlled or registered under the repository's terms and the Certificate of Confidentiality, and a data use agreement may be required.

Locations

US (1)