What are the knowledge gaps? There is still much to learn about the potential benefits and adverse effects of psychedelics (psilocybin), including how they may be influenced by preexisting conditions or used in combination with psychotherapy. The effects of psychedelics can be difficult to predict and may depend on factors such as the dosage and unique biology of the person receiving the treatment. Moreover, data are limited since many of these clinical trials have been conducted on small groups of participants.
- In blind clinical trials, participants are typically randomly selected to receive either a treatment or a placebo without being told which. This allows researchers to more easily differentiate between the effects of a given treatment and any placebo effect, in which participants who receive a placebo still report a benefit because they expect that the treatment will help.
Because of the distinct effects of psychedelics on recipients, it is difficult to prevent trial participants from knowing whether they received the treatment. This may complicate efforts to design such trials and interpret their findings. Clinical trials have tried to work around this by using an active placebo, such as a low dose of a psychedelic. Alternatively, researchers might compare the treatment with a more typical one, such as an SSRI.
Opportunities
- Mental health. Research has shown that psychedelics, such as psilocybin and MDMA, decrease fear and anxiety, with the potential to positively affect behavior in combination with therapy. For example, a clinical trial with patients with treatment-resistant PTSD demonstrated that combining MDMA and psychotherapy was effective, well-tolerated, and had no major adverse effects years later.
- Pain management. Psychedelics appear to show promise for patients with certain headache disorders and cancer pain. According to a few studies, drugs such as LSD and psilocybin appeared to alter pain perception by activating serotonin receptors and reducing inflammation.
Challenges
- Accessibility. LSD, MDMA, and psilocybin remain illegal at the federal level, categorized as Schedule I substances, which have no federally approved medical uses. To conduct research on these drugs, scientists need to follow several steps. These include obtaining permission from the U.S. Drug Enforcement Administration, finding clinical grade drugs to test, and identifying appropriate spaces in which to test and store these drugs.
- Federal approval. Difficulties associated with conducting large, blind trials of psychedelics have limited researchers’ ability to determine the safety and effectiveness of these drugs, which is required for them to gain approval from the Food and Drug Administration (FDA). FDA approval is generally required before prescription drugs can be marketed for sale in the U.S.
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