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.

Status Withdrawn
Results Published No
Start date 18 August 2009
End date 17 September 2014
Chance of happening 0%
Phase Phase II
Design Open
Type Interventional
Generation First
Participants 0
Sex All
Age 18- 99
Therapy Yes

Trial Details

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.

NCT Number NCT00979693

Sponsors & Collaborators

MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Measures Used

Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a frequently used self-rating scale developed to assess psychological distress in non-psychiatric patients.

State-Trait Anxiety Inventory
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. The STAI measures two types of anxiety – state anxiety, anxiety about an event, and trait anxiety, anxiety level as a personal characteristic.

Hamilton Anxiety Scale
The Hamilton Anxiety Scale (HAM-A) was one of the first rating scales developed to measure the severity of anxiety symptoms and is still widely used today in both clinical and research settings.

Data attribution

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