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Psilocybin-assisted Treatment for Cannabis Use Disorder

NCT06660381 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-18

No results posted yet for this study

Summary

This pilot study will evaluate the therapeutic potential of psilocybin in people with Cannabis Use Disorder (CUD). This study will examine the impact of psilocybin treatment on cannabis use and related variables in 12 people with CUD. This is an open-label proof-of-concept trial in which participants will complete a 12-week course of study treatment including two psilocybin sessions with psychological support, and follow-up assessments 3 and 6 months after the first psilocybin session.

Conditions

  • Cannabis Use Disorder

Interventions

DRUG

Psilocybin

Participants will receive a moderately high dose (25mg) of psilocybin in week 5 of the 12-week counseling, and either another moderately high dose (25mg) or a high dose (35mg) in week 7.

Sponsors & Collaborators

Principal Investigators

  • Albert Garcia-Romeu, Ph.D. · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-08
Primary Completion
2026-11-30
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06660381 on ClinicalTrials.gov