Psilocybin in the Treatment of Methamphetamine Use Disorder
Peter Hendricks
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).
Description
Single-site, phased UG3/UH3 randomized, quadruple-masked, parallel-group controlled trial (target N = 42). Participants are randomized 1:1 to a single administration of psilocybin at one of two dose levels, each delivered with a manualized platform of two preparation and two integration sessions. The specific doses are withheld in this registration during the conduct of the trial to preserve masking and reduce expectancy effects, and will be reported with results. The UG3 phase (n = 12) establishes feasibility and safety; the UH3 phase (n = 30) expands enrollment with longer follow-up. Support…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * Pregnancy or breastfeeding,…
Interventions
- DrugPsilocybin (single oral capsule administered at one of two dose levels, Dose A or Dose B; specific doses withheld during conduct).
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.
- BehavioralManualized cognitive behavioral therapy platform (2 preparation + 2 integration sessions).
Manualized CBT, adapted from Hendricks et al. (2026; https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2848757)
Location
- University of Alabama at BirminghamBirmingham, Alabama