Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants

Официальное название

Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in a Randomized, Placebo-controlled, Cross-over Trial in Healthy Participants (LPD-Study)

Обзор

The primary objective of this study is to determine whether equivalent moderately high doses of LSD, psilocybin, and DMT produce qualitatively similar peak effects when the effect duration is standardized with ketanserin. A DMT infusion mimicking oral LSD and psilocybin administrations will be tested, as well as intravenously administered ketanserin.

Подробное описание

Lysergic acid diethylamide (LSD), psilocybin, and N,N-dimethyltryptamine (DMT) are serotonergic hallucinogens (psychedelics) and currently investigated as therapeutic tools for the treatment of various psychiatric disorders. They are usually administered in a dose range which induces an alteration of consciousness via the stimulation of the serotonin (5-HT)2A receptor. However, there are differences in the receptor activation profiles between the three substances that may induce different subjective effects. Moreover, they exhibit different pharmacokinetic qualities. In comparative studies of LSD and psilocybin blinding was impaired by the different duration of subjective effects. This study aims to ensure blinding by ending all experiences at the same time with the 5HT2A antagonist ketanserin. Moreover, no study has yet directly compared DMT to LSD and psilocybin. The DMT infusion will be modeled in accordance with the course of an oral LSD and psilocybin administration. Therefore, the LPD-study compares the acute and subacute effects of LSD, psilocybin, and DMT while standardizing the time course and the duration of action for all substances.

Вмешательства

• Препарат LSD
  A moderate to high oral dose of 150 µg LSD will be administered followed by 20 mg intravenous ketanserin after 3 h
• Препарат Psilocybin
  A moderate to high oral dose of 30 mg psilocybin will be administered followed by 20 mg intravenous ketanserin after 3 h
• Препарат DMT
  A moderate to high, dose-escalating, intravenous infusion up to 2 mg/min DMT will be administered followed by 20 mg intravenous ketanserin after 3 h
• Препарат Placebo
  An oral and an intravenous placebo will be administered followed by 20 mg intravenous ketanserin after 3 h

Первичные конечные точки

• 1. Altered state of consciousness profile (5D-ASC) [Срок оценки: 18 months]

Вторичные конечные точки (12)

• Subjective effects (VASs) [Срок оценки: 18 months]
• Mystical-type experiences (PES) [Срок оценки: 18 months]
• Mystical-type experiences (PAE-PS-ext) [Срок оценки: 18 months]
• 3. Emotional breakthrough inventory (EBI+) [Срок оценки: 18 months]
• Plasma levels of LSD [Срок оценки: 18 months]
• Plasma levels of psilocybin [Срок оценки: 18 months]
• Plasma levels of DMT [Срок оценки: 18 months]
• Plasma levels of ketanserin [Срок оценки: 18 months]
• Plasma levels of oxytocin [Срок оценки: 18 months]
• Plasma levels of prolactin [Срок оценки: 18 months]
• Plasma levels of cortisol [Срок оценки: 18 months]
• Autonomic effects I [Срок оценки: 18 months]

Критерии участия

Критерии включения

• Good understanding of the German language
• Understanding of procedures and risks associated with the study
• Willing to adhere to the protocol and signing of the consent form
• Willing to refrain from the consumption of illicit psychoactive substances during the study
• Willing not to operate heavy machinery within 48 h after administration of a study substance
• Willing to use effective birth control throughout study participation
• Body mass index 17 - 34.9 kg/m2

Критерии исключения

• Relevant chronic or acute medical condition
• Current or previous major psychiatric disorder (e.g. psychotic disorder)
• Psychotic disorder or bipolar disorder in first-degree relatives
• Hypertension (SBP>140/90 mmHg) or hypotension (SBP<85 mmHg)
• Bradycardia (< 45 bpm)
• Prolonged QTc interval (males: >450 ms, females: >470 ms)
• AV block II° (Mobitz type and Webckebach type) and III°
• Hallucinogenic substance use (not including cannabis) more than 20 times or any time within the previous two months
• Pregnancy or current breastfeeding
• Participation in another clinical trial (currently or within the last 30 days)
• Use of medication that may interfere with the effects of the study medication
• Tobacco smoking (>10 cigarettes/day)
• Excessive consumption of alcoholic beverages (>15 drinks/week)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Тройное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швейцария · 1 центр

• University Hospital — Basel

Идентификаторы

NCT: NCT06899334 · BASEC 2024-01445

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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