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Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma

NCT00979693 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-12-26

No results posted yet for this study

Summary

This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin. The study will measure anxiety, depression, quality of life and spirituality before and after psilocybin-assisted psychotherapy, natural killer cells (a type of immune cell) will be counted from blood samples taken the day after psilocybin-assisted psychotherapy, and people will keep daily diaries reporting on how anxious they feel for each day in the study.

Conditions

Interventions

DRUG

psilocybin

25 mg psilocybin administered orally once during each of the two day-long psychotherapy sessions.

DRUG

psilocybin

4 mg psilocybin orally administered once during each of two day-long psychotherapy session

Sponsors & Collaborators

  • Multidisciplinary Association for Psychedelic Studies

    lead OTHER

Principal Investigators

  • Sameet Kumar, Ph.D · Psycho-oncologist, Mount Sinai Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-04-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00979693 on ClinicalTrials.gov