Psychedelic-Assisted Therapy: What’s Approved and Investigational

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Psychedelic-assisted therapy uses psychedelic substances combined with therapeutic support. Psychedelic assisted therapy is rapidly evolving field with some approved applications and many in research.

Current approved psychedelic therapy

Esketamine (Spravato):

  • FDA-approved 2019
  • Nasal spray for TRD
  • Insurance covered
  • Most established psychedelic-adjacent therapy

IV ketamine (off-label):

  • Used in many clinics
  • Not FDA-approved for depression
  • Not insurance covered typically

Investigational/limited access

Psilocybin:

  • FDA Breakthrough designation for depression
  • Phase 3 trials ongoing
  • Oregon legal program
  • Colorado developing

MDMA:

  • FDA rejected approval 2024 for PTSD despite Phase 3 data
  • Methodology concerns
  • Research continues

LSD, ayahuasca, others:

  • Earlier-stage research
  • Various contexts

Common features

Psychedelic-assisted therapy typically involves:

  • Preparation sessions
  • Dosing session(s) with therapist support
  • Integration sessions
  • Set and setting emphasis
  • Therapist relationship important

Conditions being studied

  • Treatment-resistant depression
  • PTSD
  • Substance use disorders
  • End-of-life anxiety
  • OCD
  • Eating disorders

Risks and screening

Important considerations:

  • Psychosis history typically excludes
  • Bipolar disorder caution
  • Cardiovascular conditions screening
  • Drug interactions (especially serotonergic medications)
  • Difficult psychological experiences possible
  • Need for proper supervision

The legal gray zone

Various entities offer psychedelic services in unclear legal contexts:

  • Religious exemptions claimed
  • State-level legal programs
  • Underground therapists
  • Risks vary

Frequently Asked Questions

What psychedelic therapy is currently legal?

Spravato (FDA-approved). Psilocybin in Oregon. Limited contexts otherwise.

Should I try ketamine therapy?

For TRD, reasonable option in supervised settings.

Will MDMA-assisted therapy become legal?

FDA rejected 2024. Research continues. Future uncertain.

What about psilocybin clinical trials?

Active. Search clinicaltrials.gov.

Is psychedelic therapy a breakthrough?

Promising for some conditions but evidence still building. Not panacea.

The bottom line on psychedelic-assisted therapy

Field rapidly evolving. Spravato/ketamine established options. Other psychedelics in research with various legal status. Pursue through proper channels.

Medical Disclaimer: The information in this article is for educational purposes only and is not intended as medical advice. Always consult with a qualified healthcare professional before making any health-related decisions.

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