Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Psilocybin-assisted Psychotherapy in the Management of Anxiety Associated With Stage IV Melanoma.|
- Hospital Anxiety and Depression Scale [ 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 ] [ Designated as safety issue: No ]
- Spielberger-State-Trait Inventory (STAI) [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Hamilton Anxiety Rating Scale [ Time Frame: Baseline, non-drug psychotherapy between sessions, two weeks after second experimental session ] [ Designated as safety issue: No ]
- Natural killer (NK) cell count [ Time Frame: Day after experimental session 1, day after experimental session 2 ] [ Designated as safety issue: No ]
- European Organization For Research and Treatment of Cancer; Quality of Life Questionnaire-C15 [ Time Frame: 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 ] [ Designated as safety issue: No ]
- Hamilton Depression Rating Scale [ Time Frame: Baseline, non-drug psychotherapy in between experimental sessions, two weeks after second experimental session ] [ Designated as safety issue: No ]
- Functional Assessment of Chronic Illness Therapy-spirituality [ Time Frame: Baseline, first intro psychotherapy sesison, day of experimental session 1, non-drug psychotherapy between experimental sessions, day of experimental session 2, two weeks after second experimental session ] [ Designated as safety issue: No ]
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Full Dose
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.
25 mg psilocybin administered orally once during each of the two day-long psychotherapy sessions.
Active Comparator: Active Placebo
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.
4 mg psilocybin orally administered once during each of two day-long psychotherapy session
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.
|United States, Florida|
|Mount Sinai Comprehensive Cancer Center|
|Miami Beach, Florida, United States, 33140|
|Principal Investigator:||Sameet Kumar, Ph.D||Psycho-oncologist, Mount Sinai Comprehensive Cancer Center|