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Not yet taking people in United StatesPhase 2

Psilocybin for Methamphetamine Use Disorder

Key facts

Who runs it
Peter Hendricks
Where
Birmingham, United StatesSee the site
Trial code
Status
Not yet recruiting
Phase
Phase 2
People taking part
42 people, planned
Starts
1 Feb 2027
Expected to end
1 Feb 2032
Type of study
Interventional, 2 groups
Treatments tested
  • Psilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).
  • Manualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
Record updated
21 September 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • Regular use of centrally acting serotonergic medications or MAO inhibitors (washout/re-screen permitted)
  • 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
  • Current psychiatric diagnoses other than a mild substance use disorder or tobacco/nicotine use disorder
  • Current hypertension (>140/90 at rest)
  • Personal history of any psychotic or bipolar I/II disorder, or a first- or second-degree relative with such
  • Pregnancy or breastfeeding, or not using effective contraception
  • Current suicidal or homicidal ideation
  • Plan to relocate within 6 months

Where in United States

  • University of Alabama at BirminghamBirmingham, United StatesContact: Seher Premani, MPHNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • Psilocybin, Dose ATreatment being tested

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

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

  • Psilocybin, Dose BTreatment being tested

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

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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Psilocybin in the Treatment of Methamphetamine Use Disorder
Record updated
21 September 2026