Clinical TrialAnxiety DisordersPsilocybinPsilocybinWithdrawn

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

Randomised, quadruple-blind, parallel pilot study (n randomized) of two doses of psilocybin (25 mg vs 4 mg) given in two day-long psychotherapy sessions to treat anxiety in people with stage IV melanoma.

Target Enrollment
Not specified
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, quadruple-blind, parallel-group pilot trial comparing two oral doses of psilocybin (25 mg versus 4 mg) delivered in two day-long psychotherapy sessions scheduled 7–14 days apart in adults with stage IV melanoma and new-onset anxiety.

Primary outcomes include measures of anxiety, depression, quality of life and spirituality; immune outcome: natural killer cell counts from blood samples taken the day after psilocybin sessions; safety assessed with labs and adverse event monitoring.

Procedures include two preparatory psychotherapy sessions, overnight stay after dosing, psychotherapy follow-up the day after each session and additional follow-up two weeks after the second session; subjects receiving low-dose active placebo may be offered an open-label phase.

Study Protocol

Preparation

2 sessions

Dosing

2 sessions
480 min each

Integration

3 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Full dose

experimental

25 mg psilocybin administered in two day-long psychotherapy sessions 7–14 days apart.

Interventions

  • Psilocybin25 mg
    via Oral• two sessions• 2 doses total

    Two day-long sessions; sessions scheduled 7–14 days apart; overnight stay.

Active placebo

active comparator

4 mg psilocybin administered in two day-long psychotherapy sessions 7–14 days apart (active placebo).

Interventions

  • Psilocybin4 mg
    via Oral• two sessions• 2 doses total

    Active placebo (low dose psilocybin); two day-long sessions; sessions 7–14 days apart.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • 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 functioning.
  • 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

  • Exclusion Criteria:
  • Meet DSM-IV criteria for bipolar disorder, schizophrenia, or other psychotic disorders.
  • 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 melanoma.
  • 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.

Study Details

Locations

Mount Sinai Comprehensive Cancer Center — Miami Beach, Florida, United States

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