Effects of Psilocybin in Patients With Amyotrophic Lateral Sclerosis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT06656702
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Psilocybin — DRUG
    Psilocybin Trihydrate. Participants will complete an 8-week course of study treatment including two psilocybin sessions (15 mg in week 4 and 15 or 25 mg in week 6), with follow-up assessments 1, 3, and 6 months after the final psilocybin session.

Study Details

This study aims to study the feasibility of psilocybin therapy for patients with Amyotropic Lateral Sclerosis (ALS) with depressed mood. The secondary objective is to assess its impact on depression, quality of life, hopelessness, and functional status in this patient population.

Key Dates

Start date
Apr 9, 2025
Status verified
Jan 2026
Primary completion
Jan 30, 2027
Completion
Jul 1, 2027

Study Design

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

Arms

  • Other: Psilocybin
    All subjects will be in the same, open label arm

Primary Outcome Measure

Feasibility of psilocybin treatment as assessed by number of participants recruited, retained and adhere to treatment [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimoreMaryland21224
Ian Geithner, MPS
[email protected]
410-550-0037
Albert Garcia-Romeu, Ph.D.
[email protected]
410-550-1972

Find similar trials in Baltimore, MD

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

Related Studies