Psilocybin-Assisted Psychotherapy in Patients With Advanced Cancer on Maintenance Therapy

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06200155
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Depression, Anxiety
  • Psilocybin-Assisted Psychotherapy

Eligibility Criteria

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

Interventions

  • Psilocybin — DRUG
    Given by PO
  • Niacin — OTHER
    Given by PO

Study Details

To learn about the feasibility, safety, and effects of psilocybin-assisted psychotherapy on depression and/or anxiety in participants who are being treated for advanced cancer.

Key Dates

Start date
Apr 16, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm A
    Participants will receive psilocybin (25 mg).
  • Placebo Comparator: Arm B
    Participants will receive the placebo (100 mg of Niacin).

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Moran Amit, MD
[email protected]
713-794-5304
Moran Amit, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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