Psilocybin for Methamphetamine Use Disorder
ConditionMethamphetamine Use Disorder
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter Hendricks
About 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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- 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).
Treatment groups
42 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peter Hendricks
Lead sponsor
University of Alabama at Birmingham
Sponsor institution
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov