Not Yet RecruitingPhase 2psilocybin

Psilocybin for Methamphetamine Use Disorder

NCT ID

NCT07774702

Target Enrollment

42 participants

Start Date

2027-02-01

Est. Completion

2032-02-01

About This Study

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 Studied

Methamphetamine Use Disorder

Interventions

•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).

Eligibility

Age:18 Years - N/A

Healthy Volunteers:No

View full eligibility criteria

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, 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

Study Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States