Psilocybin for Methamphetamine Use Disorder

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Peter Hendricks
Study ID
NCT07774702
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Methamphetamine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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)

Study Details

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).

Key Dates

First listed
Aug 19, 2026
Start date
Feb 1, 2027
Status verified
Aug 2026
Primary completion
Feb 1, 2032
Completion
Feb 1, 2032

Study Design

Enrollment
42 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin, Dose A
    Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).
  • Experimental: Psilocybin, Dose B
    Single oral dose during an 8-hour supervised session (Specific dose withheld during conduct).

Primary Outcome Measure

Abstinent Days [ Time Frame: Baseline through 90-day follow-up (UG3) and 180-day follow-up (UH3). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294
Seher Premani, MPH
[email protected]
205-975-7721
Noah Sweat, BS
[email protected]
205-996-0212
Peter S Hendricks, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Alabama at Birmingham· Birmingham, AL

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