Psilocybin-assisted Therapy for Comorbid Major Depressive Disorder and Alcohol Use Disorder
This study is investigating a new treatment called psilocybin-assisted therapy for adults who are struggling with both major depression and alcohol addiction. Researchers aim to find out how safe and practical this therapy is by comparing it to a dummy treatment (placebo). They will monitor participants closely to see if there are side effects or if people stop participating. The main goal is to understand if this therapy could be a helpful option for these conditions, looking at things like how well people tolerate it and any significant differences between the treatment and placebo groups.
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¿De qué trata este estudio?
This study is a clinical trial looking into a new way to help people who are experiencing both depression and alcohol problems at the same time. It's called psilocybin-assisted therapy. Psilocybin is a substance that, in a controlled medical setting, is being explored for its potential therapeutic effects. The therapy involves carefully guided sessions to help participants explore their thoughts and feelings.
The main aim of this research is to understand if this therapy is safe and if it could be an effective treatment for these two challenging conditions. Researchers want to see how easy it is to carry out this type of treatment, how well people tolerate it, and if there are any major side effects. They will be comparing the real treatment with a 'placebo' – a dummy treatment that looks just like the real thing, but without the active substance. This helps them understand what effects are truly due to the psilocybin.
By comparing these two groups, scientists hope to learn if psilocybin-assisted therapy can make a real difference for people with major depression and alcohol use disorder. They are looking for clear answers on whether it's a helpful and manageable treatment option for the future.
Puntos clave
- This study explores a new therapy for depression and alcohol problems.
- It uses psilocybin in a guided therapy setting.
- You might receive real psilocybin or a placebo (dummy treatment).
- Participation involves 14 visits, some in-person, some remote.
- You would need to stop certain current medications if deemed safe by your doctor.
- The study aims to understand its safety and effectiveness.
¿Quién puede ser elegible?
This study is looking for adults aged between 18 and 65 years old. To join, you need to understand the study and be able to provide your agreement to take part. You should also be able to read and communicate in English well enough to understand the study materials.
You must have a diagnosis of both major depression (without psychotic features) and a moderate or severe alcohol use disorder. It's important that you're not currently taking antidepressant, antipsychotic, or certain anti-alcohol medications, and you must be willing to stop other specific medications if your doctor confirms it's safe for you to do so.
For women who could become pregnant, you would need to use effective contraception before and during the study. You should also be generally healthy enough for the study procedures and willing to follow the treatment plan.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- ¿Tienes entre 18 y 65 años?
- Do you have a diagnosis of both major depression and alcohol dependence?
- Are you willing and able to stop certain medications if your doctor says it's safe?
- Can you understand and speak English well enough for the study?
- Are you able to use effective contraception if you could become pregnant?
- Are you generally healthy enough to take part?
¿En qué consiste la participación?
If you join this study, you will be randomly assigned to either receive the psilocybin treatment or a placebo (a dummy treatment). You will have a total of 14 visits, which will be a mix of in-person appointments and remote check-ins. During these visits, you'll complete various tasks related to the study.
The psilocybin-assisted therapy itself will happen at five different times throughout the study. This means you won't be taking the treatment every day, but at specific appointments. The total duration of your participation will include these visits and follow-ups to monitor your progress and safety.
Riesgos y beneficios potenciales
Ubicaciones (1)
- Centre for Addiction and Mental HealthCódigo postal verificadoToronto, Canadá
Preguntas comunes
What is psilocybin-assisted therapy?
It's a treatment under study where psilocybin, a substance from certain mushrooms, is given in a controlled medical setting alongside therapy sessions to help with mental health conditions. It's not the same as recreational use.
Will I know if I'm getting the real drug or a placebo?
No, you won't know because the study is 'blinded.' This is important so researchers can accurately measure the true effects of the psilocybin compared to the dummy treatment.
Can I keep taking my current depression or alcohol medication?
Generally no, you would need to stop certain medications before and during the study. Your doctor would need to agree that it's safe for you to do this.
What does 'comorbid' mean?
Comorbid means having two medical conditions at the same time. In this study, it refers to experiencing both major depression and alcohol use disorder.
How many times will I visit the clinic?
You will have 14 visits in total, which will include both in-person appointments and remote (online or phone) check-ups.
Cómo obtener más información
Bernard Le Foll
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.