Psilocybin in Cancer Pain Study

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Yvan Beaussant, MD, MSci
Study ID
NCT06001749
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Cancer
  • Advanced Cancers
  • Opioid-Related Disorders
  • Pain Management
  • Pain Management and Care

Eligibility Criteria

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

Interventions

  • Psilocybin — DRUG
    A tryptamine derivative, capsule, taken orally.

Study Details

The overall objective of this study is to assess the feasibility, safety and preliminary efficacy of psilocybin-assisted therapy to alleviate opioid-refractory pain in patients with advanced-cancer. The name of the study intervention used in this research study is: Psilocybin (a tryptamine derivative)

Key Dates

Start date
Sep 23, 2024
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Psilocybin
    Participants will complete study procedures as follows: * 2, in-clinic or remote, preparation sessions with therapists. * In-clinic treatment session with therapists at Dana-Farber Cancer Institute. Participants will take a predetermined amount of psilocybin once. Participants will be transported home by a friend or family member. * In-clinic integration session the day after psilocybin administration with therapists. * In-clinic or remote, integration session with therapists 1 week after psilocybin administration. * In-clinic or remote follow visits with therapists at week 2, 3, 5, 8, and 12 after psilocybin administration.

Primary Outcome Measure

Feasibility of Psilocybin-Assisted Therapy [ Time Frame: 3 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215
Isabel Kristan
[email protected]
8572151476
Yvan Beaussant, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dana-Farber Cancer Institute· Boston, MA

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