Psilocybin Therapy in Advanced Cancer

Part of paid clinical trials in Aurora, Colorado.

Sponsor
NYU Langone Health
Study ID
NCT05398484
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
21 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin 25 mgs — DRUG
    One capsule containing 25mg of psilocybin will be administered with water orally. The appearance of psilocybin is Size 2 HPMC opaque.
  • Niacin 100mg — DRUG
    One capsule contains 100mg of niacin will be administered with water orally. The appearance of the active placebo is Size 2 HPMC opaque.
  • Psychotherapy — BEHAVIORAL
    The manualized psychotherapy platform will consist of 6 hours of preparatory psychotherapy (prior to the single medication session) and 8 hours of integration psychotherapy following the dosing session.

Study Details

The purpose of this research is to study the safety and effects of single-dose psilocybin 25mg versus an active placebo (single dose niacin 100mg) in the treatment of anxiety, depression, and existential distress (i.e., loss of meaning and hope; fear of death) in advanced cancer (i.e., stage 3 or 4). Study medications will be administered in conjunction with brief psychotherapy that is designed to treat anxiety, depression and existential distress in advanced cancer.

Key Dates

Start date
May 24, 2023
Status verified
Dec 2025
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants receiving Study Drug
    Advanced cancer participants will receive experimental medication, psilocybin (25mg). In addition to the pharmacologic intervention, participants will receive a manualized psychotherapy platform. The combination of interventions is referred to as psilocybin-assisted psychotherapy (PAP).
  • Active Comparator: Participants receiving Placebo
    Advanced cancer participants will receive active placebo - single dose of niacin (100mg). In addition to the placebo, participants will receive the same manualized psychotherapy platform as the experimental arm.

Primary Outcome Measure

Change in Structured Interview Guide for the Hamilton Anxiety Scale (HAM-A): SIGH-A Score [ Time Frame: Baseline, Week 8 ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Colorado Anschutz Medical campus (CU AMC)AuroraColorado80045
Stacy Fischer, MD
[email protected]
303-724-2406
Mary Mancuso
[email protected]
303-724-5729
Stacy Fischer, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone HealthNew YorkNew York10016
Sydney Weiner, MA
[email protected]
212-263-6283
Stephen Ross, MD
[email protected]
212-263-6289
Stephen Ross, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By research site
University of Colorado Anschutz Medical campus (CU AMC)· Aurora, CONYU Langone Health· New York, NY

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