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

NCT00979693 | Withdrawn Phase 2

• 1 other identifier: PCA1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Anxiety; Stage IV Melanoma

Keywords

anxiety; stage IV melanoma; depression; spirituality; pain

Outcome Measures

Primary Outcomes (1)

• Hospital Anxiety and Depression Scale

  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

Secondary Outcomes (6)

• Spielberger-State-Trait Inventory (STAI)

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

• Hamilton Anxiety Rating Scale

  Baseline, non-drug psychotherapy between sessions, two weeks after second experimental session

• Natural killer (NK) cell count

  Day after experimental session 1, day after experimental session 2

• European Organization For Research and Treatment of Cancer; Quality of Life Questionnaire-C15

  Baseline, 1st intro psychotherapy, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks post second experimental session

• Hamilton Depression Rating Scale

  Baseline, non-drug psychotherapy in between experimental sessions, two weeks after second experimental session

Study Arms (2)

Full Dose

EXPERIMENTAL

Participant will receive 25 mg psilocybin during two day-long sessions of psychotherapy in combination with psilocybin, with each session scheduled seven to 14 days apart.

Drug: psilocybin

Active Placebo

ACTIVE COMPARATOR

The participant will receive 4 mg psilocybin during two day-long sessions of psychotherapy in combination with psilocybin, with sessions scheduled seven to 14 days apart.

Drug: psilocybin

Interventions

psilocybin DRUG

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

Full Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Multidisciplinary Association for Psychedelic Studies: lead

Study Sites (1)

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Melanoma; Depression; Pain

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Mental Disorders; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Sameet Kumar, Ph.D

  Psycho-oncologist, Mount Sinai Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2009
• First Posted: September 18, 2009
• Study Start: January 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

US (1)