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Hallucinogens are psychoactive substances that profoundly alter perceptual experiences, generating unreal visual and sensory images. Often referred to as psychedelic drugs — a term derived from the Greek words "psyche" (mind) and "delos" (revealing) — these substances include marijuana and lysergic acid diethylamide (LSD), among others. These drugs vary in intensity and effects.
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Hallucinogens, also known as psychedelic drugs, are a class of substances known for their ability to alter perception, cognition, and emotions. Despite their profound effects on the mind, these drugs are non-addictive, setting them apart from many other abused substances. The mechanism of action of these drugs lies in their impact on the 5-HT2A receptor in the brain. Upon activation, this receptor couples to Gq-type G proteins, triggering a cascade that releases intracellular calcium. This...
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Practical considerations in the establishment of psychedelic research programs.

Brian S Barnett1,2, M Frances Vest3, Marcus S Delatte4

  • 1Department of Psychiatry and Psychology, Neurological Institute, Cleveland Clinic, Lutheran Hospital, 1730 W 25th Street Floor 5E, Cleveland, OH, 44113, USA.

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Establishing psychedelic research programs at academic centers requires navigating significant regulatory and logistical hurdles. Early planning and institutional support are crucial for overcoming these challenges in psychedelic drug development.

Keywords:
Clinical researchClinical trialsLSDPsilocybinPsychedelics

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Area of Science:

  • Neuroscience and Pharmacology
  • Psychiatry and Clinical Psychology
  • Regulatory Science

Background:

  • Growing interest in psychedelic research at academic medical centers.
  • Psychedelics present unique challenges due to psychoactivity, sociopolitical factors, and Schedule I status.
  • Lack of formal guidance for investigators establishing psychedelic research programs.

Purpose of the Study:

  • Provide recommendations for investigators working with psychedelics.
  • Focus on establishing psychedelic research within U.S. academic medical centers.
  • Offer practical guidance for navigating implementation obstacles.

Main Methods:

  • Review of academic literature on relevant topics.
  • Incorporation of author experiences from regulatory agencies and diverse research settings (basic science, investigator-initiated trials, industry-sponsored trials).

Main Results:

  • Cultivating broad institutional support is essential for psychedelic research.
  • Anticipate challenges in funding, FDA Investigational New Drug (IND) approval, and sourcing clinical-grade psychedelics.
  • Secure Drug Enforcement Administration (DEA) Schedule I researcher registration and state licenses; prepare facilities for treatment and drug storage; manage controlled substance inventory; and engage the local community.

Conclusions:

  • Implementation of psychedelic research faces several anticipated challenges.
  • These challenges are surmountable with thorough planning, persistence, and expert collaboration.
  • Successful establishment of psychedelic research programs is feasible with strategic foresight.