Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study

NCT01878942 | Completed Early Phase 1 DMC

• 1 other identifier: EK 279/12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the acute psychological, physiological, endocrine, and pharmacokinetic, as well as long-term psychological effects of LSD in humans.

Conditions

Healthy

Keywords

LSD; Pharmacology; Pharmacokinetics; Pharmacodynamics; Mechanism of action; Psychedelic; Serotonin; Prepulse inhibition; LSD-induced neuroendocrine effects; Long-term psychological effects

Outcome Measures

Primary Outcomes (1)

• Subjective / psychological effects of LSD

  repeated assessment of subjective effects with validated questionnaires

  24 hours

Secondary Outcomes (8)

• Physiological effects of LSD

  24 hours

• Endocrine response of LSD

  24 hours

• Pharmacokinetics of LSD

  24 hours

• Effect of LSD on prepulse inhibition

  3 hours

• Tolerability of LSD

  24 hours

Study Arms (1)

Placebo, LSD

OTHER

Cross-over within-subjects design with all treatment conditions tested in the same subject. This design has 1 arm but two treatment conditions in the same subject.

Drug: Placebo; Drug: LSD

Interventions

Placebo DRUG

Capsules containing mannitol looking identical to LSD per os

Placebo, LSD

LSD DRUG

200µg per os, single dose

Also known as: Lysergic acid diethylamide

Placebo, LSD

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 25 and 65 years
• Understanding of the German language
• Understanding the procedures and the risks associated with the study
• Participants must be willing to adhere to the protocol and sign the consent form
• Participants must be willing to refrain from taking illicit psychoactive substances during the study
• Participants must be willing to drink only alcohol-free liquids and no xanthine-containing liquids (such as coffee, black or green tea, red bull, chocolate) after midnight of the evening before the study session, as well as during the study day.
• Participants must be willing not to drive a traffic vehicle within 48 h following LSD administration.
• Women of childbearing potential must have a negative pregnancy test at the beginning of the study and must agree to use an effective form of birth control. Pregnancy tests are repeated before each study session.

You may not qualify if:

• Chronic or acute medical condition including clinically relevant abnormality in physical exam, laboratory values, or ECG. In particular: Hypertension (\>150/95 mmHg). Personal or first-grade history of seizures. Cardiac or neurological disorder.
• Current or previous psychotic or major affective disorder
• Psychotic or major affective disorder in first-degree relatives
• Relevant prior illicit drug use (except tetrahydrocannabinol (THC)-containing products) more than 10 times or any time within the previous 2 months.
• Pregnant or nursing women.
• Participation in another clinical trial (currently or within the last 30 days)
• Use of medications that may interfere with the effects of the study medications (any psychiatric medications)
• Insufficient interpersonal relationship/rapport with study physician as judged by the study physician

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (5)

• Schmid Y, Liechti ME. Long-lasting subjective effects of LSD in normal subjects. Psychopharmacology (Berl). 2018 Feb;235(2):535-545. doi: 10.1007/s00213-017-4733-3. Epub 2017 Sep 16.

  PMID: 28918441 DERIVED

• Dolder PC, Schmid Y, Steuer AE, Kraemer T, Rentsch KM, Hammann F, Liechti ME. Pharmacokinetics and Pharmacodynamics of Lysergic Acid Diethylamide in Healthy Subjects. Clin Pharmacokinet. 2017 Oct;56(10):1219-1230. doi: 10.1007/s40262-017-0513-9.

  PMID: 28197931 DERIVED

• Liechti ME, Dolder PC, Schmid Y. Alterations of consciousness and mystical-type experiences after acute LSD in humans. Psychopharmacology (Berl). 2017 May;234(9-10):1499-1510. doi: 10.1007/s00213-016-4453-0. Epub 2016 Oct 7.

  PMID: 27714429 DERIVED

• Dolder PC, Schmid Y, Muller F, Borgwardt S, Liechti ME. LSD Acutely Impairs Fear Recognition and Enhances Emotional Empathy and Sociality. Neuropsychopharmacology. 2016 Oct;41(11):2638-46. doi: 10.1038/npp.2016.82. Epub 2016 Jun 1.

  PMID: 27249781 DERIVED

• Schmid Y, Enzler F, Gasser P, Grouzmann E, Preller KH, Vollenweider FX, Brenneisen R, Muller F, Borgwardt S, Liechti ME. Acute Effects of Lysergic Acid Diethylamide in Healthy Subjects. Biol Psychiatry. 2015 Oct 15;78(8):544-53. doi: 10.1016/j.biopsych.2014.11.015. Epub 2014 Nov 29.

  PMID: 25575620 DERIVED

MeSH Terms

Interventions

Lysergic Acid Diethylamide

Intervention Hierarchy (Ancestors)

Lysergic Acid; Ergolines; Ergot Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Officials

• Matthias E Liechti, MD, MAS

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: June 17, 2013
• Study Start: June 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 21, 2016

Record last verified: 2016-01

Locations

CH (1)