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Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.

Phase 2
18 Years
Not Enrolling
Anxiety, Malignant Melanoma of Skin Stage IV

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Trial Information

Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.

Melanoma is a cancer arising from pigment-producing cells, or melanocytes. These cells are
chiefly located in the skin, but they can also be found in other parts of the body,
including eyes, ears and GI tract. A diagnosis of stage IV melanoma can create great stress
and anxiety for an individual and his or her caregivers. Psilocybin (4-phosphoryloxy-
N,N-dimethyl-tryptamine) is a psychedelic (hallucinogenic) compound found in certain species
of mushrooms that can produce spiritual or mystical experiences and that has been used in
psychotherapy prior to being made illegal. This study will be a randomized, active-placebo
controlled pilot study of the safety and efficacy of psilocybin-assisted psychotherapy as a
means of managing anxiety in association with stage IV melanoma. This study will examine
whether two sessions of psilocybin-assisted psychotherapy scheduled seen to 14 days apart
will reduce anxiety, improve quality of life and be safe in people with stage IV melanoma.

Subjects in this study will have a 66% chance of receiving the full dose of 25 mg psilocybin
and a 33% of receiving 4 mg psilocybin. The first dose is expected to change how people
feel, think and see the world, while the lower dose is expected to have only slight effects.
Each subject will receive these conditions at random, as if by coin-toss. The researchers,
including the therapists, and the subject will not know whether they are assigned to get 25
or 4 mg psilocybin.

The entire study can last up to three and a half months (14 weeks) but the main part of the
study lasts six weeks. After the researchers determine that a person with stage IV melanoma
and anxiety can be in the study, there will be two introductory psychotherapy sessions with
the therapist-investigators. They will prepare the participant for psilocybin-assisted
psychotherapy. The subject will have a day-long psilocybin-assisted psychotherapy session
after introductory sessions, and he or she will remain overnight at the clinic. There will
be a psychotherapy follow-up scheduled the day after each psilocybin-assisted session to
help people work with the psilocybin-assisted psychotherapy, and there will be a
psychotherapy session in between the first and second psilocybin-assisted psychotherapy
sessions. Two weeks after the second psilocybin-assisted psychotherapy session, subjects
will return for another follow-up visit. The subjects will answer questions or fill out
questionnaires about anxiety, depression, quality of life, spirituality and sense of self at
the start of the study, two weeks after the second psilocybin-assisted session and at least
once during the study. Subjects will have blood draws to assess liver function before each
psilocybin-assisted session and they will have a blood draw to assess natural killer (NK)
cells the day after each psilocybin-assisted session. On the day after each
psilocybin-assisted session, subjects will also complete a questionnaire about their
experiences during the psilocybin-assisted session.

Two weeks after the second experimental psilocybin-assisted session, subjects will learn if
they got the full or active placebo dose of psilocybin. Any of the three subjects who
receive the active placebo dose can take part in an "open-label" study phase that will last
another six weeks. The open-label phase will be nearly identical to those used in the first
study phase except that there will be one, and not two, introductory psychotherapy sessions,
and the subject and therapists will know that the subject will be receiving 25 mg
psilocybin. People who got the full dose of 25 mg psilocybin will not take part in the
open-label study phase.

If they are well enough to do so, subjects who received the full dose of psilocybin will
have anxiety, depression, quality of life and spirituality measured again two months after
the second experimental session. Subjects who received active placebo psilocybin will have
anxiety, depression, quality of life and spirituality measured two months after the second
open-label psilocybin-assisted session.

Inclusion Criteria:

- Have been diagnosed with Stage IV melanoma with a life expectancy of one year or less

- Meet diagnostic criteria for anxiety on the SCID, or a score of 8 or higher on the
HADS Anxiety score.

- Diagnosis must be a new diagnosis of anxiety subsequent to diagnosis with melanoma.

- Are 18 years or older

- Live with another adult who is their primary caregiver, who can also provide
transportation to and from the cancer center for each experimental session and who
also consents to take part in a parallel investigation of anxiety and depression in
primary caregivers. The same caregiver may remain overnight with participants after
each psilocybin session.

- Have a Mini-Mental State Exam score of 27 or higher, an indication of mental

- Are willing to commit to medication dosing, experimental sessions with overnight
stay, traveling to follow-up sessions, and to complete the evaluation

- Are willing to refrain from taking any anti-depressants during the study period.

- Are willing to refrain from taking any benzodiazepines during the 24 hours preceding
each scheduled psilocybin, placebo, or open label session.

- Are able to communicate in English.

Exclusion Criteria:

- Meet DSM-IV criteria for bipolar disorder, schizophrenia, or other psychotic

- Meet DSM-IV criteria for abuse of or dependence on any substance (other than caffeine
or nicotine) in the past 60 days.

- Have first-degree relatives (as parent or full sibling) with past or present
psychiatric disorders, including schizophrenia, bipolar affective disorder and other
psychoses, but excluding mood disorders.

- Cannot have a current diagnosis of anxiety disorder that predates diagnosis with

- Have used psilocybin or psilocybin-containing mushrooms within the past year.

- Require concomitant treatment with anti-psychotic medications, prescribed for the
management of either psychiatric symptoms or nausea. The restriction on 5HT2C/5HT3
antagonists is applicable for 24 hours before and including the day of the study.

- Are cachectic [exhibiting signs of wasting] as indicated by loss of 10% or greater of
their total weight.

- Have been diagnosed with primary or metastatic cancer of the CNS confirmed by MRI,
within 6 weeks of participation in the study.

- Have uncontrolled hypertension.

- Have baseline laboratory values indicative of severely compromised hepatic function,
indicated by unacceptable levels of alkaline phosphatase (ALP) above 750 U/L.
Participants must also have laboratory blood screening indicating ALP below 750 U/L
immediately prior to administration of psilocybin.

- Are women who are pregnant or nursing, or of child bearing potential and are not
practicing an effective means of birth control.

- Are reasonably judged to present a serious suicide or homicide risk or who are likely
to require psychiatric hospitalization during the course of the study.

- Are unable to fully understand the potential risks and benefits of the study and give
informed consent.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Hospital Anxiety and Depression Scale

Outcome Time Frame:

Baseline, 1st non-drug intro psychotherapy, day of psilocybin-assited psychotherapy, non-drug psychotherapy between experimental sessions, day of psilocybin-assisted session 2, two weeks after second psilocybin-assisted session

Safety Issue:


Principal Investigator

Sameet Kumar, Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Psycho-oncologist, Mount Sinai Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

January 2012

Completion Date:

June 2013

Related Keywords:

  • Anxiety
  • Malignant Melanoma of Skin Stage IV
  • anxiety
  • stage IV melanoma
  • depression
  • spirituality
  • pain
  • Anxiety Disorders
  • Melanoma
  • Skin Neoplasms



Mount Sinai Comprehensive Cancer CenterMiami Beach, Florida  33140