Although not yet approved by the FDA, evidence from trials suggests psychedelic therapy may help treat mental health conditions including depression, anxiety, PTSD and bipolar disorders. A single administration of a psychedelic drug in a controlled environment has been shown to provide mental health relief for extended periods. But not everyone reacts the same, and patients may have what’s known as a bad trip.
However, the general view is that psychedelic-assisted therapy is helpful and the risk of an adverse reaction is low. In 2023, the FDA issued draft guidelines supporting clinical trials for psychedelic drugs.
What Is Psychedelic-Assisted Therapy?
This form of therapy involves the administration of a hallucinogenic drug in a controlled and supervised setting. The quantity of the drug is carefully chosen, and a licensed therapist is on hand throughout the session. Psychedelic-assisted therapy sessions may last from 4 to 10 hours.
Before administration of the drug, the patient receives counseling to create a supportive relationship and help prepare them for the experience. Follow-up sessions help the individual achieve beneficial behavioral changes.
Substances Used in Psychedelic Assisted Therapy
Classic psychedelic substances are serotonin 2A receptor agonists, which means they activate serotonin receptors and increase serotonin in the central nervous system. These include psilocybin, LSD and DMT. Non-classic psychedelics, including MDMA and ketamine, have similar effects but through different mechanisms.
- Psilocybin Therapy
Psilocybin is a naturally occurring substance found in certain mushrooms, hence the nickname “mushroom drugs.” Psilocybin converts into psilocin, a chemical that interrupts communication between networks in the brain. The drug alters perceptions and is thought to help the brain return to a healthier state. Trials showed patients with major depressive disorder who received a single dose of psilocybin had a 16% higher remission rate than those who received a placebo. - DMT
Dimethyltryptamine (DMT) is a naturally occurring psychedelic traditionally used by South American indigenous peoples. Small trials have shown the inhalation of a single 60 mg dose resulted in half the participants maintaining remission from treatment-resistant depression (TRD) after 1 month. - LSD
Lysergic acid diethylamide (LSD) is a synthetic classic psychedelic developed in 1943. Current trials center around using LSD to relieve anxiety and comorbid depression. One trial showed a significant, long-lasting reduction in anxiety and related depression for up to 16 weeks. - MDMA
Commonly known as ecstasy, 3,4-methylenedioxymethamphetamine is a non-classic psychedelic that helps patients with PTSD. In a trial conducted by the University of California, San Francisco, patients who took MDMA together with psychotherapy were twice as likely to recover from PTSD trauma as a control group. - Ketamine
Although it may cause hallucinations and dissociation, ketamine isn’t a psychedelic in the traditional sense. It’s primarily used as an anesthetic, but a derivative, esketamine, was approved by the FDA in 2019 for the treatment of depression. The drug is also being used by trained professionals for the treatment of PTSD, TRD and related mood disorders.
Psychological and Physical Risks to Consider
Although psychedelic therapy performed under proper supervision is considered relatively safe, the psychedelic experience is intense, and patients may experience adverse psychological and physical symptoms. These may include:
- Panic
- Rapid heart rate
- Dizziness
- Nausea
- Psychological distress
- Disorientation
- Confusion
- Flashbacks
- Scary hallucinations
Adverse symptoms usually disappear as the effect of the drug wears off, but some patients experience long-lasting consequences, especially in poorly supervised and uncontrolled environments. Longer-term risks of psychedelic therapy include anxiety, depression and a worsening of bipolar disorder and schizophrenia symptoms.
Concerns Around Regulation, Setting and Supervision
Psychedelic trials are performed in carefully controlled environments with high levels of clinical supervision. Except for esketamine, no psychedelic treatments have FDA approval, although many have been granted breakthrough designations, which allow researchers to undertake closely supervised clinical trials.
- Regulatory Concerns
In most states, the use of psychedelics is illegal except for approved breakthrough therapies. However, several states allow the use of certain psychedelic drugs under specified conditions. The off-label use of ketamine is allowed, hence the emergence of IV ketamine therapies. - Settings
Psychedelic therapy should be administered in a conducive environment such as a warm, quiet and comfortable room, free from outside noise or disruptions. Soothing music is usually played, and the patient wears an eye mask to avoid distraction. - Supervision
The session should be closely supervised by a trained therapist who remains in the room for the duration of the treatment, which could last up to 8 hours. The therapist provides constant reassurance to the patient and conducts therapeutic sessions before and after the psychedelic treatment.
Who May Not Be a Good Candidate for Psychedelic Therapy
Not everyone is a suitable candidate for psychedelic therapy. In a recent study, up to 16% of volunteer participants fell into what was defined as a negative responder subcategory. Researchers noted that people with an existing personality or psychotic disorder faced a higher risk of experiencing negative reactions.
From a purely medical perspective, researchers at the University of California, San Francisco, recommend candidates with certain medical conditions be excluded because of the increase in blood pressure and heart rate commonly experienced during therapy. These include:
- Pregnant women
- People with epilepsy or a history of seizures
- Those with cardiovascular diseases
- Individuals with a history of heart attack or stroke
Additionally, patients taking selective serotonin reuptake inhibitors (SSRI) or monoamine oxidase enzyme (MAO-I) antidepressants that increase serotonin levels in the brain should be excluded.
How to Weigh the Potential Benefits Against the Risks
Psychedelics are considered to have low toxicity, but the main risk arises from their psychological effects. These include distressing side effects such as panic attacks, dissociation, confusion and increased heart rate. Another concern is the possibility of engaging in risky behavior during which patients may harm themselves or others.
Conversely, these therapies may provide quick and long-lasting results compared to conventional medications and therapies. They often work where conventional treatments fail.
To counter these risks, treatment must be conducted by trained therapists under carefully controlled conditions. Therapists should have an established relationship with the patient and a comprehensive understanding of their psychological and physical conditions.
Getting Help for Mental Health Conditions
Sunlight Recovery’s compassionate team of psychiatrists provides round-the-clock care for those with mental health conditions. We offer cutting-edge treatments customized to individual needs. If you or a loved one is struggling with a mental health condition, contact us to start treatment today.
