Psychedelic substances, such as psilocybin and MDMA, have shown promising results in clinical trials for hard-to-treat mental health conditions, such as treatment-resistant depression, cancer-related distress and post-traumatic stress disorder.
However, these substances also induce profound changes in perception, mood and cognition, which pose unique ethical and regulatory challenges for informed consent procedures. In this article, we review some of these challenges and propose some possible solutions to ensure that patients are adequately informed and protected when receiving psychedelic treatments.
However, psychedelic treatments are not like conventional pharmacological interventions. They require a combination of drug administration and psychological support or psychotherapy, which may involve preparation, integration and guidance sessions. The psychotherapy component is not only for safety reasons, but also for enhancing the clinical efficacy of the drug by modulating the subjective experience of the patient.
This means that informed consent for psychedelic treatments is not just about the risks and benefits of the drug, but also about the nature and goals of the psychotherapy. Informed consent is a process that aims to respect the autonomy and dignity of patients by providing them with adequate information and ensuring their voluntary agreement to participate in a treatment. However, obtaining informed consent for psychedelic treatments may be challenging for several reasons.
First, psychedelic treatments involve inducing an altered state of consciousness that may affect the patient’s ability to understand, remember and evaluate information during and after the session. This may impair their decision-making capacity and compromise their consent.
For example, some patients may experience confusion, dissociation, memory impairment or suggestibility under the influence of psychedelics.
These effects may make them more vulnerable to manipulation or coercion by the therapist or researcher.
Second, psychedelic treatments may elicit profound emotional, cognitive and spiritual experiences that may be difficult to anticipate or describe in advance. These experiences may have lasting impacts on the patient’s beliefs, values, identity and worldview. For example, some patients may report mystical or religious experiences, insights into their personal problems or relationships, or changes in their sense of self or reality. These effects may be beneficial or harmful depending on the individual and the context.
Third, psychedelic treatments may involve a high degree of trust and rapport between the patient and the therapist or researcher. This may create a power imbalance that may affect the patient’s consent. For example, some patients may feel pressured to agree to participate in a treatment or to disclose personal information because of their gratitude, admiration or dependence on the therapist or researcher. Alternatively, some patients may feel reluctant to participate in a treatment or to share their experiences because of their fear, shame or distrust of the therapist or researcher.
These challenges suggest that informed consent for psychedelic treatments needs to be enhanced beyond the standard procedures for clinical trials or practice. Some possible strategies to enhance informed consent are:
- Providing clear and comprehensive information about the drug and the psychotherapy components of the treatment, including their risks and benefits, possible outcomes and alternatives.
- Providing information in multiple formats (such as written, oral and visual) and at multiple time points (such as before, during and after the session).
- Assessing the patient’s understanding and voluntariness throughout the process using standardized tools or methods.
- Supporting the patient’s decision-making capacity by addressing any factors that may impair it (such as mental state, cognitive impairment or emotional distress).
- Respecting the patient’s right to withdraw consent at any time without negative consequences.
- Ensuring that the patient’s privacy and confidentiality are protected during and after the session.
- Establishing a therapeutic alliance with the patient based on mutual respect, empathy and honesty.
- Providing adequate follow-up and support for the patient after the session to help them integrate their experiences and cope with any adverse effects.
Psychedelic treatments for mental health conditions pose challenges for informed consent that require careful attention and consideration. By enhancing informed consent procedures, we can ensure that patients are treated with respect and dignity, and that they can benefit from these novel interventions in a safe and ethical manner.
After this long premise, let’s go deeper into the individual topics………
What are psychedelic substances and how do they work?
Psychedelic substances are a class of drugs that act on the serotonin system in the brain and produce acute psychoactive effects, such as altered states of consciousness, visual hallucinations, emotional changes and mystical experiences. Some of the most well-known psychedelic substances are lysergic acid diethylamide (LSD) and psilocybin (the active ingredient in magic mushrooms).
These are considered typical psychedelics, as they share a common molecular structure and pharmacological profile. There are also atypical psychedelics, such as ketamine and 3,4-methylenedioxymethamphetamine (MDMA), which have different chemical structures and mechanisms of action, but also induce some degree of altered consciousness and psychoactive effects.
Psychedelic substances have been used for centuries by various cultures for religious, spiritual and therapeutic purposes. However, they were banned in most countries in the 1960s and 1970s due to their association with the counterculture movement and their potential for abuse and adverse effects.
Since then, scientific research on psychedelics has been largely restricted and stigmatized. However, in recent years, there has been a resurgence of interest and evidence for the therapeutic potential of psychedelics for various mental health conditions that are often resistant to conventional treatments.
Psychedelic treatments involve the administration of a single or a few doses of a psychedelic substance under controlled and supervised conditions, usually accompanied by some form of psychological support or psychotherapy. The psychological intervention is intended to enhance the safety and efficacy of the treatment by preparing the patient for the experience, guiding them through it and helping them integrate it afterwards.
The therapeutic effects of psychedelics are thought to depend not only on the pharmacological action of the drug, but also on the subjective experience that it induces, which can be influenced by various factors such as the setting, the therapist and the patient’s expectations.
What are the benefits and risks of psychedelic treatments?
Several clinical trials have shown that psychedelic treatments can produce rapid and lasting improvements in symptoms of depression, anxiety, post-traumatic stress disorder (PTSD), addiction and other mental health conditions. Some studies have also reported positive changes in personality traits, such as openness and optimism, as well as enhanced well-being, spirituality and quality of life. These effects seem to be mediated by neurobiological mechanisms that involve neuroplasticity, neurogenesis, neuroinflammation and modulation of brain networks involved in emotion regulation, cognition and self-awareness.
However, psychedelic treatments also carry some risks and challenges that need to be carefully considered and managed. The most common adverse effects of psychedelics are transient physical symptoms such as nausea, headache, dizziness and increased blood pressure. These are usually mild and manageable with appropriate medical supervision. More serious physical complications are rare but possible, especially if there are underlying medical conditions or interactions with other drugs.
The main psychological risks of psychedelics are related to the acute psychoactive effects that they induce. These can include anxiety, paranoia, confusion, delusions, psychosis and suicidal ideation. These are more likely to occur if the patient has a history of psychiatric disorders or trauma,
source : https://neurosciencenews.com/psychedelic-mental-health-ptsd-23483/