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Psilocybin Clinical Trials

LSD Treatment in Persons Suffering From Anxiety Symptoms in Severe Somatic Diseases or in Psychiatric Anxiety Disorders: a Randomized, Double-blind, Placebo-controlled Phase II Study

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Id: NCT03153579

Organisation Name: University Hospital, Basel, Switzerland

Overal Status: Completed

Start Date: June 23, 2017

Last Update: December 22, 2021

Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary: Background: Lysergic acid diethylamide (LSD) was extensively investigated in humans in the 1950s and 1960s. Particularly, LSD attenuated anxiety in patients with cancer. Clinical research with LSD ended in the 1970s due to regulatory restrictions but its use for personal and recreational purposes continued. In recent years, there has been a renewed interest in the use hallucinogens in psychiatric research and practices. LSD and psilocybin were reused in experimental studies in healthy subjects and in the treatment for anxiety in patients with life-threatening diseases. Specifically, a pilot study documented that LSD can be used safely and may reduce anxiety in these patients. Larger well-designed and placebo-controlled studies are warranted. Similar studies have recently been completed with the hallucinogen psilocybin.

Objective: To test the efficacy of LSD in patients with anxiety with or without life-threatening diseases.

Design: Double-blind, placebo-controlled random-order cross-over trial using two LSD (200 µg) and two placebo sessions with subjects acting as their own control.

Participants: 40 patients aged > 25 years with anxiety disorder (according to DSM-IV or a state-trait anxiety inventory score >40 in the STAI trait or state scale) with or without life-threatening illness.

Main outcome measures: Reduction in anxiety (STAI), depression (Hamilton depression rating scale, HDRS and Beck depression inventory, BDI), and general psychopathological symptoms (Symptom Check List 90 items, SCL-90) at 2, 8, and 16 weeks after LSD- compared with placebo-assisted psychotherapy.

Significance: Anxiety disorder (alone or in the context of life-threatening illness) is frequent and often insufficiently managed with available medications. This study will evaluate the potential benefits of single treatments with LSD in anxiety disorder.

  • Patients
  • Anxiety Disorders

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