Study of Psilocybin Assisted Psychotherapy to Address Fear of Recurrence

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06430541
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    A tryptamine that produces its behavioral effects primarily by acting as post-synaptic agonists at serotonin 5-HT2A and 5-HT2c receptors.

Study Details

The goal of this clinical trial is to test whether psilocybin along with therapy in women with early breast cancer and ovarian cancer in remission can improve their fear of recurrence. The main question\[s\] it aims to answer \[is/are\]: Does psilocybin assisted therapy improve fear of cancer recurrence? Does psilocybin assisted therapy improve anxiety, depression, and quality of life? Participants will complete a series of survey measures, participate in preparatory therapy. After prep therapy is complete, they will receive a moderately high dose of psilocybin in a monitored and supportive environment. After the dosing day, they will complete 4 sessions of integrative therapy and complete survey measures.

Key Dates

Start date
Nov 21, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Psilocybin Assisted Psychotherapy
    25mg cGMP Psilocybin in combination with manualized therapy

Primary Outcome Measure

Change in Fear of Cancer Recurrence Inventory [ Time Frame: 1-week, 4-weeks, 8-weeks* (primary outcome time point), 12-weeks, and 24-weeks. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Outpatient CTRCAuroraColorado80045
Stacy Fischer, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado Cancer CenterAuroraColorado80045
Stacy Fischer, MD
[email protected]
303-724-2406
Stacy Fischer, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Breast cancerOvarian cancer
By specialty
OncologyBreast oncologyWomen's healthGynecologic oncology
By research site
Outpatient CTRC· Aurora, COUniversity of Colorado Cancer Center· Aurora, CO

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