Psilocybin-assisted Treatment for Cannabis Use Disorder

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06660381
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Cannabis Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    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.

Study Details

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.

Key Dates

Start date
Nov 8, 2024
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Psilocybin
    Open-label psilocybin will be administered with psychological support to each participant at two dosing sessions approximately 2 weeks apart.

Primary Outcome Measure

Self-reported cannabis use as assessed by a modified Timeline Follow-Back interview [ Time Frame: Baseline, weekly up to 3 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21224
Ian Geithner, MPS
[email protected]
786-239-7990
Albert Garcia-Romeu, PhD
[email protected]

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By research site
Johns Hopkins Center for Psychedelic and Consciousness Research· Baltimore, MD

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